9,418 Project Qa jobs in the United States
QA Specialist, DSM (Project QA)
27540 Holly Springs, North Carolina
Fujifilm
Posted today
Job Viewed
Job Description
**Position Overview**
The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
**Company Overview**
**Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO**
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
**Join us**
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
**Job Description**
**What You'll Do**
- Performs a role within the QA team for the development of documents, processes, and procedures for the DSM program
- Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
- Provides QA oversight and supports DSM operations in accordance with governing processes and procedures
- Provides QA support of DSM tasks such as
o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool
o Real time event triage and implementation of immediate response to identified deviations
o Area changeover and return to service
o Real time WO oversight per applicable procedures
- Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs
- Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
- Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites
- Perform other duties, as assigned
**Minimum Requirements**
- BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR
- Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience
- 1-3 years' experience in a GMP environment
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
**Preferred Requirements**
- 2+ years of experience in GMP Quality Assurance and/or similar role
- Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
**Working & Physical Conditions**
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**EEO Information**
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
**ADA Information**
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _3 days ago_ _(5/5/2025 10:13 AM)_
**_Requisition ID_** _2025-34489_
**_Category_** _Quality Assurance_
**_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_
The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
**Company Overview**
**Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO**
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
**Join us**
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
**Job Description**
**What You'll Do**
- Performs a role within the QA team for the development of documents, processes, and procedures for the DSM program
- Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
- Provides QA oversight and supports DSM operations in accordance with governing processes and procedures
- Provides QA support of DSM tasks such as
o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool
o Real time event triage and implementation of immediate response to identified deviations
o Area changeover and return to service
o Real time WO oversight per applicable procedures
- Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs
- Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
- Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites
- Perform other duties, as assigned
**Minimum Requirements**
- BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR
- Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience
- 1-3 years' experience in a GMP environment
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
**Preferred Requirements**
- 2+ years of experience in GMP Quality Assurance and/or similar role
- Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
**Working & Physical Conditions**
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**EEO Information**
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
**ADA Information**
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _3 days ago_ _(5/5/2025 10:13 AM)_
**_Requisition ID_** _2025-34489_
**_Category_** _Quality Assurance_
**_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_
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0
QA Specialist, DSM (Project QA)
27540 Holly Springs, North Carolina
FUJIFILM Diosynth Biotechnologies
Posted 8 days ago
Job Viewed
Job Description
Position Overview
The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
Company Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
Job Description
What You'll Do
* Performs a role within the QA team for the development of documents, processes, and procedures for the DSM program• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures• Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites• Perform other duties, as assigned
Minimum Requirements
* BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR• Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience• 1-3 years' experience in a GMP environment• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
Preferred Requirements
* 2+ years of experience in GMP Quality Assurance and/or similar role• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
Working & Physical Conditions
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
Company Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies has never been more important-and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
Job Description
What You'll Do
* Performs a role within the QA team for the development of documents, processes, and procedures for the DSM program• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems• Provides QA oversight and supports DSM operations in accordance with governing processes and procedures• Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites• Perform other duties, as assigned
Minimum Requirements
* BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR• Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience• 1-3 years' experience in a GMP environment• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
Preferred Requirements
* 2+ years of experience in GMP Quality Assurance and/or similar role• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
Working & Physical Conditions
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
View Now
1
QA Engineer, DSM (Project QA)
27540 Holly Springs, North Carolina
FUJIFILM Corporation
Posted 4 days ago
Job Viewed
Job Description
Position Overview
The QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project phase through to operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day‐to‐day activities and resolution or mitigation of issues.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:
Job Description
What You'll Do
• Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
• Ensures project and operational quality objectives are met within desired timelines
• Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
• Participates in optimization or improvement initiatives and support regulatory agency and third‐party inspections
• Performs other duties as assigned
Minimum Requirements
• BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR
• MS in Life Sciences or Engineering and 3+ years of applicable experience OR
• PhD in Life Sciences or Engineering and 1+ years of applicable experience
• 3+ years of experience in a GMP environment
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
• High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
Preferred Requirements
• Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
• Experience with startup projects or initiatives
Working & Physical Conditions
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
EEO Information
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
ADA Information
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
Job Locations US-NC-Holly Springs
Posted Date 4 months ago (5/5/2025 10:20 AM)
Requisition ID 2025-34491
Category Quality Assurance
Company (Portal Searching) FUJIFILM Biotechnologies
View Now
2
QA Specialist, DSM (Project QA)
27540 Holly Springs, North Carolina
Fujifilm
Posted 4 days ago
Job Viewed
Job Description
**Position Overview**
The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
**Company Overview**
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Description**
**What You'll Do**
- Performs a role within the QA team for the development of documents, processes, and procedures for the DSM program
- Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
- Provides QA oversight and supports DSM operations in accordance with governing processes and procedures
- Provides QA support of DSM tasks such as
o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool
o Real time event triage and implementation of immediate response to identified deviations
o Area changeover and return to service
o Real time WO oversight per applicable procedures
- Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs
- Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
- Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites
- Perform other duties, as assigned
**Minimum Requirements**
- BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR
- Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience
- 1-3 years' experience in a GMP environment
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
**Preferred Requirements**
- 2+ years of experience in GMP Quality Assurance and/or similar role
- Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
**Working & Physical Conditions**
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**EEO Information**
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
**ADA Information**
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _4 months ago_ _(5/5/2025 10:13 AM)_
**_Requisition ID_** _2025-34489_
**_Category_** _Quality Assurance_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_
The QA Specialist, Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable DSM systems and processes are operated/maintained in a validated state throughout their lifecycle, with a focus on consistent policy administration. The QA Specialist, Drug Substance Manufacturing (DSM) ensures QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.
**Company Overview**
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Description**
**What You'll Do**
- Performs a role within the QA team for the development of documents, processes, and procedures for the DSM program
- Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
- Provides QA oversight and supports DSM operations in accordance with governing processes and procedures
- Provides QA support of DSM tasks such as
o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool
o Real time event triage and implementation of immediate response to identified deviations
o Area changeover and return to service
o Real time WO oversight per applicable procedures
- Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs
- Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
- Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites
- Perform other duties, as assigned
**Minimum Requirements**
- BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR
- Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience
- 1-3 years' experience in a GMP environment
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
**Preferred Requirements**
- 2+ years of experience in GMP Quality Assurance and/or similar role
- Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
**Working & Physical Conditions**
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**EEO Information**
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
**ADA Information**
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _4 months ago_ _(5/5/2025 10:13 AM)_
**_Requisition ID_** _2025-34489_
**_Category_** _Quality Assurance_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_
View Now
3
QA Engineer, DSM (Project QA)
27540 Holly Springs, North Carolina
Fujifilm
Posted 4 days ago
Job Viewed
Job Description
**Position Overview**
The QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project phase through to operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day‐to‐day activities and resolution or mitigation of issues.
**Company Overview**
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Description**
**What You'll Do**
- Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program
- Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation
- Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
- Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
- Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
- Ensures project and operational quality objectives are met within desired timelines
- Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
- Participates in optimization or improvement initiatives and support regulatory agency and third‐party inspections
- Performs other duties as assigned
**Minimum Requirements**
- BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR
- MS in Life Sciences or Engineering and 3+ years of applicable experience OR
- PhD in Life Sciences or Engineering and 1+ years of applicable experience
- 3+ years of experience in a GMP environment
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
- High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
**Preferred Requirements**
- Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
- Experience with startup projects or initiatives
**Working & Physical Conditions**
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**EEO Information**
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
**ADA Information**
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _4 months ago_ _(5/5/2025 10:20 AM)_
**_Requisition ID_** _2025-34491_
**_Category_** _Quality Assurance_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_
The QA Engineer, DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during project phase through to operational readiness. The QA Engineer, DSM is responsible for quality assurance oversight of day‐to‐day activities and resolution or mitigation of issues.
**Company Overview**
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Description**
**What You'll Do**
- Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program
- Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation
- Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
- Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
- Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
- Ensures project and operational quality objectives are met within desired timelines
- Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
- Participates in optimization or improvement initiatives and support regulatory agency and third‐party inspections
- Performs other duties as assigned
**Minimum Requirements**
- BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience OR
- MS in Life Sciences or Engineering and 3+ years of applicable experience OR
- PhD in Life Sciences or Engineering and 1+ years of applicable experience
- 3+ years of experience in a GMP environment
- Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
- High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies
**Preferred Requirements**
- Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
- Experience with startup projects or initiatives
**Working & Physical Conditions**
Ability to discern audible cues.
Ability to stand for prolonged periods of time up to 120 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
Ability to conduct activities using repetitive motions that include wrists, hands or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.
_To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid._
**EEO Information**
Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.
**ADA Information**
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
**Job Locations** _US-NC-Holly Springs_
**Posted Date** _4 months ago_ _(5/5/2025 10:20 AM)_
**_Requisition ID_** _2025-34491_
**_Category_** _Quality Assurance_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_
View Now
4
Project Coordinator - QA/QC
94025 Menlo Park, California
Tutor Perini
Posted today
Job Viewed
Job Description
**Expected hourly rate for this position is $30.00 - $35.00 depending on experience**
Rudolph & Sletten, a Tutor Perini Company, is seeking a **Project Coordinator - QAQC** to join our project office in Palo Alto, CA.
**About Rudolph & Sletten:**
In the last six decades, Rudolph and Sletten has built thousands of projects across our five California offices, from research centers designed to cure _diseases_ to institutions that educate future generations to civic facilities and high-tech campuses that move our state forward.
Just like the buildings we construct, our reputation is built to stand the test of time. Our success is due to our diverse, talented personnel, technological expertise, honest estimates, innovative schedules, and ethical business practices.
We're excited to see where the future takes us. Between new building and construction technology, better earth-friendly materials and techniques, all our phenomenal employees, and the amazing people we work with, we're looking forward to building more award-winning projects for decades to come.
Our client focus and technical expertise have made us a builder of choice for clients for over 6 decades. Notable clients include Johnson and Johnson, Gilead, Salk Institute, Western Digital, Oracle, Seagate, Intuit, San Diego Symphony, Kaiser Permanente, Cedars-Sinai, the Judicial Council of California, and UC and CSU higher education systems.
At Rudolph & Sletten you will have the opportunity to work on a variety of large, high-profile, projects that impact your community.
**_Extraordinary Projects need Exceptional Talent. Let's Build_**
**DESCRIPTION:**
The Project Coordinator- QA/QC provides administrative support to the jobsite project team. Responsible to ensure smooth day to day activities on the project site, including site office equipment and supply management and to assist with document administration and tracking of all associated construction compliances. This position may be located at a regional office OR at a construction project site and candidate must have the flexibility to change construction projects as needed.
**Essential Duties and Responsibilities:**
+ Read all the subcontractors Daily Reports and inform Superintendent of any concerning entries.
+ Advance inspection requests in project inspection software (Inertia) and verify submittals, times, etc.
+ Enter inspection requests into logistics tracking software (TeamUp).
+ Scan and file fire watch safety logs & construction barrier assessment logs, upload to Owner software (PMWeb).
+ Update the weekly work plans for the field TV displays.
+ Download monthly labor report from R&S tracking software (Procore), review and issue to Superintendent and Project Manager.
+ Update and upload MMRP (City of Palo Alto reporting requirement) monthly with project changes.
+ Get signatures for R&S field timecards, scan and return to Main Office Admin and Field Superintendent.
+ Download, read and file special inspector reports.
+ Download and file jobsite Inspector of Record reports.
+ Track subcontractor upcoming inspections (based on previous week's Inspection Reports).
+ Help populate the finish protection matrix by reviewing project specifications.
+ Take meeting minutes for Foreman meeting (when needed).
**REQUIREMENTS:**
+ Education: High school diploma required, Associate's degree preferred
+ Construction industry experience preferred, but not required. Office experience highly desired.
+ Ability to effectively communicate and participate actively in a critical role as part of a team environment
+ Manage multiple tasks, produce quality work on time-sensitive deadlines while remaining flexible and able to pivot between tasks as needed
+ Ability to establish and maintain relationships with key stakeholders in other Departments and projects to assist in resolving mutual issues or to develop improved processes
+ Excel proficiency and use of overall MS Office Suite
+ Project Management Software (Procore), JD Edwards E1 (Financial) & Bluebeam pdf experience are helpful
+ Egnyte or similar cloud platform content sharing experience a plus
+ Adept in learning new software quickly and able to navigate and use to review, track, and upload various documents
**_Rudolph & Sletten_** **_builds extraordinary projects with exceptional talent. Join us and together we will build the future_**
**Equal Opportunity Employer**
Rudolph & Sletten, a Tutor Perini Company, is seeking a **Project Coordinator - QAQC** to join our project office in Palo Alto, CA.
**About Rudolph & Sletten:**
In the last six decades, Rudolph and Sletten has built thousands of projects across our five California offices, from research centers designed to cure _diseases_ to institutions that educate future generations to civic facilities and high-tech campuses that move our state forward.
Just like the buildings we construct, our reputation is built to stand the test of time. Our success is due to our diverse, talented personnel, technological expertise, honest estimates, innovative schedules, and ethical business practices.
We're excited to see where the future takes us. Between new building and construction technology, better earth-friendly materials and techniques, all our phenomenal employees, and the amazing people we work with, we're looking forward to building more award-winning projects for decades to come.
Our client focus and technical expertise have made us a builder of choice for clients for over 6 decades. Notable clients include Johnson and Johnson, Gilead, Salk Institute, Western Digital, Oracle, Seagate, Intuit, San Diego Symphony, Kaiser Permanente, Cedars-Sinai, the Judicial Council of California, and UC and CSU higher education systems.
At Rudolph & Sletten you will have the opportunity to work on a variety of large, high-profile, projects that impact your community.
**_Extraordinary Projects need Exceptional Talent. Let's Build_**
**DESCRIPTION:**
The Project Coordinator- QA/QC provides administrative support to the jobsite project team. Responsible to ensure smooth day to day activities on the project site, including site office equipment and supply management and to assist with document administration and tracking of all associated construction compliances. This position may be located at a regional office OR at a construction project site and candidate must have the flexibility to change construction projects as needed.
**Essential Duties and Responsibilities:**
+ Read all the subcontractors Daily Reports and inform Superintendent of any concerning entries.
+ Advance inspection requests in project inspection software (Inertia) and verify submittals, times, etc.
+ Enter inspection requests into logistics tracking software (TeamUp).
+ Scan and file fire watch safety logs & construction barrier assessment logs, upload to Owner software (PMWeb).
+ Update the weekly work plans for the field TV displays.
+ Download monthly labor report from R&S tracking software (Procore), review and issue to Superintendent and Project Manager.
+ Update and upload MMRP (City of Palo Alto reporting requirement) monthly with project changes.
+ Get signatures for R&S field timecards, scan and return to Main Office Admin and Field Superintendent.
+ Download, read and file special inspector reports.
+ Download and file jobsite Inspector of Record reports.
+ Track subcontractor upcoming inspections (based on previous week's Inspection Reports).
+ Help populate the finish protection matrix by reviewing project specifications.
+ Take meeting minutes for Foreman meeting (when needed).
**REQUIREMENTS:**
+ Education: High school diploma required, Associate's degree preferred
+ Construction industry experience preferred, but not required. Office experience highly desired.
+ Ability to effectively communicate and participate actively in a critical role as part of a team environment
+ Manage multiple tasks, produce quality work on time-sensitive deadlines while remaining flexible and able to pivot between tasks as needed
+ Ability to establish and maintain relationships with key stakeholders in other Departments and projects to assist in resolving mutual issues or to develop improved processes
+ Excel proficiency and use of overall MS Office Suite
+ Project Management Software (Procore), JD Edwards E1 (Financial) & Bluebeam pdf experience are helpful
+ Egnyte or similar cloud platform content sharing experience a plus
+ Adept in learning new software quickly and able to navigate and use to review, track, and upload various documents
**_Rudolph & Sletten_** **_builds extraordinary projects with exceptional talent. Join us and together we will build the future_**
**Equal Opportunity Employer**
View Now
5
Project Engineer, QA/QC
10176 New York, New York
APTIM
Posted 4 days ago
Job Viewed
Job Description
**Job Overview:**
APTIM is seeking an experienced Engineer to support an ongoing long-term design-build project in Brooklyn, NY. This is a field position to support the QA/QC activities for the Brooklyn project. Responsibilities may also include supporting additional APTIM Projects as needed.
**Key Responsibilities/Accountabilities:**
+ Managing Project Quality Control Plan implementation by the project team
+ Responsible for the implementation and documentation of the Three Phase Inspection Process that helps ensure the project is constructed with the approved materials in accordance with the approved design.
+ Responsible for collaboration with the Engineer of Record on the interpretation of design elements to address field conditions and construction related issues that may impact the project schedule.
+ Serve as the project Vibration Specialist documenting and reporting vibration levels at structures adjacent to ongoing construction activities.
+ Responsible for evaluating and reporting data trends of optical monitoring data measuring displacement of buildings, bridges, and bulkheads.
+ Complete Daily Quality Control Reports documenting ongoing inspection activities.
+ Maintains frequent and consistent verbal and written communication with clients, partners, and APTIM leadership on the status of the project.
+ Identifies conflicts, requests, and requirements and liaisons with the engineering team
**Basic Qualifications:**
+ Requires Bachelors of Science degree in Engineering or related field from an accredited program. Geotechnical, Civil or Structural fields preferred.
+ Licensed New York State Professional Engineer
+ 10-20 years minimum relevant experience
+ 5+ years of relevant vibration experience
+ USACE CQM Certification, a plus
+ Strong written and verbal communication skills
+ 40 Hour Hazwoper Training, a plus
+ Working knowledge of Microsoft suite
+ Ability to quickly acquire a working knowledge of project-specific standards, procedures, and correspondence
+ Well organized and confident in communicating to clients and internal team
**ABOUT APTIM**
APTIM is committed to accelerating the transition toward a clean and efficient energy economy, building a sustainable future for our communities and natural world, and creating a more inclusive and equitable environment that celebrates the diversity of our communities. We specialize in environmental, resilience, and sustainability and energy solutions, as well as technical and data solutions, program management, and critical infrastructure. For every challenge our clients face, there is an opportunity for APTIM to innovate a fit-for-purpose solution that will raise your organization or community to a new standard of excellence.
What you can expect from APTIM:
+ Work that is worthy of your time and talent
+ Respect and flexibility to live a full life at work and at home
+ Dogged determination to deliver for our clients and communities
+ A voice in making our company better
+ Investment into your personal and professional development
**BENEFITS**
APTIM is committed to providing a benefits package that accomplishes the primary purpose of our programs, which is to protect and promote the health and financial well-being of our employees and their families.
APTIM's health care and insurance benefits include the following programs: medical, dental, vision, prescription drug, basic life insurance, optional life insurance, spouse life insurance, child life insurance, basic accidental death & dismemberment, optional accidental death and dismemberment, short- and long-term disability with optional buy-ups, employee assistance program, health care spending account, dependent care spending account, health savings account and business travel accident insurance for themselves and their eligible family members, per plan guidelines. Multiple voluntary benefits are available to employees for enrollment including critical illness, hospital indemnity, accident insurance, etc.
APTIM also provides participation in a retirement program, paid absences such as vacation time (annual days determined by length of service) and sick leave to eligible employees in accordance with the APTIM sick pay policy and as required by law.
APTIM is committed to providing a benefits package that accomplishes the primary purpose of our programs which is to protect and promote the health and financial well-being of our employees and their families. APTIM's health care and insurance benefits include the following programs: medical, dental, vision, prescription drug, basic life insurance, optional life insurance, spouse life insurance, child life insurance, basic accidental death & dismemberment, optional accidental death & dismemberment, short- and long-term disability with optional buy-ups, employee assistance program, health care spending account, dependent care spending account, health savings account and business travel accident insurance for themselves and their eligible family members, per plan guidelines. Multiple voluntary benefits are available to employees for enrollment including critical illness, hospital indemnity, accident insurance, etc. APTIM also provides participation in a retirement program, paid absences such as vacation time (annual days determined by length of service) and sick leave to eligible employees in accordance with the APTIM sick pay policy and as required by law. The targeted salary for this position is between $150,000.00 to $200,000.00 dependent on experience and qualifications.
**#LI-BS1 #LI-Onsite**
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may make their request known by e-mailing or calling for assistance.
EOE/Vets/Disability
APTIM is seeking an experienced Engineer to support an ongoing long-term design-build project in Brooklyn, NY. This is a field position to support the QA/QC activities for the Brooklyn project. Responsibilities may also include supporting additional APTIM Projects as needed.
**Key Responsibilities/Accountabilities:**
+ Managing Project Quality Control Plan implementation by the project team
+ Responsible for the implementation and documentation of the Three Phase Inspection Process that helps ensure the project is constructed with the approved materials in accordance with the approved design.
+ Responsible for collaboration with the Engineer of Record on the interpretation of design elements to address field conditions and construction related issues that may impact the project schedule.
+ Serve as the project Vibration Specialist documenting and reporting vibration levels at structures adjacent to ongoing construction activities.
+ Responsible for evaluating and reporting data trends of optical monitoring data measuring displacement of buildings, bridges, and bulkheads.
+ Complete Daily Quality Control Reports documenting ongoing inspection activities.
+ Maintains frequent and consistent verbal and written communication with clients, partners, and APTIM leadership on the status of the project.
+ Identifies conflicts, requests, and requirements and liaisons with the engineering team
**Basic Qualifications:**
+ Requires Bachelors of Science degree in Engineering or related field from an accredited program. Geotechnical, Civil or Structural fields preferred.
+ Licensed New York State Professional Engineer
+ 10-20 years minimum relevant experience
+ 5+ years of relevant vibration experience
+ USACE CQM Certification, a plus
+ Strong written and verbal communication skills
+ 40 Hour Hazwoper Training, a plus
+ Working knowledge of Microsoft suite
+ Ability to quickly acquire a working knowledge of project-specific standards, procedures, and correspondence
+ Well organized and confident in communicating to clients and internal team
**ABOUT APTIM**
APTIM is committed to accelerating the transition toward a clean and efficient energy economy, building a sustainable future for our communities and natural world, and creating a more inclusive and equitable environment that celebrates the diversity of our communities. We specialize in environmental, resilience, and sustainability and energy solutions, as well as technical and data solutions, program management, and critical infrastructure. For every challenge our clients face, there is an opportunity for APTIM to innovate a fit-for-purpose solution that will raise your organization or community to a new standard of excellence.
What you can expect from APTIM:
+ Work that is worthy of your time and talent
+ Respect and flexibility to live a full life at work and at home
+ Dogged determination to deliver for our clients and communities
+ A voice in making our company better
+ Investment into your personal and professional development
**BENEFITS**
APTIM is committed to providing a benefits package that accomplishes the primary purpose of our programs, which is to protect and promote the health and financial well-being of our employees and their families.
APTIM's health care and insurance benefits include the following programs: medical, dental, vision, prescription drug, basic life insurance, optional life insurance, spouse life insurance, child life insurance, basic accidental death & dismemberment, optional accidental death and dismemberment, short- and long-term disability with optional buy-ups, employee assistance program, health care spending account, dependent care spending account, health savings account and business travel accident insurance for themselves and their eligible family members, per plan guidelines. Multiple voluntary benefits are available to employees for enrollment including critical illness, hospital indemnity, accident insurance, etc.
APTIM also provides participation in a retirement program, paid absences such as vacation time (annual days determined by length of service) and sick leave to eligible employees in accordance with the APTIM sick pay policy and as required by law.
APTIM is committed to providing a benefits package that accomplishes the primary purpose of our programs which is to protect and promote the health and financial well-being of our employees and their families. APTIM's health care and insurance benefits include the following programs: medical, dental, vision, prescription drug, basic life insurance, optional life insurance, spouse life insurance, child life insurance, basic accidental death & dismemberment, optional accidental death & dismemberment, short- and long-term disability with optional buy-ups, employee assistance program, health care spending account, dependent care spending account, health savings account and business travel accident insurance for themselves and their eligible family members, per plan guidelines. Multiple voluntary benefits are available to employees for enrollment including critical illness, hospital indemnity, accident insurance, etc. APTIM also provides participation in a retirement program, paid absences such as vacation time (annual days determined by length of service) and sick leave to eligible employees in accordance with the APTIM sick pay policy and as required by law. The targeted salary for this position is between $150,000.00 to $200,000.00 dependent on experience and qualifications.
**#LI-BS1 #LI-Onsite**
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Applicants with a physical or mental disability who require a reasonable accommodation for any part of the application or hiring process may make their request known by e-mailing or calling for assistance.
EOE/Vets/Disability
View Now
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6
Quality Assurance III (Project Manager QA)
Texas, Texas
Orion Group
Posted today
Job Viewed
Job Description
Project Manager QA (Quality Assurance III)
Can be based out of North Chicago, IL or Waco, TX (Hybrid to virtual)
12-month initial contract
Hourly Pay Rate: $50-53/hr (individual medical benefits available at a cost)
The Quality Assurance Project Manager is responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by our plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Compensation is commensurate on level of overall responsibility.
Responsibilities:
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Can be based out of North Chicago, IL or Waco, TX (Hybrid to virtual)
12-month initial contract
Hourly Pay Rate: $50-53/hr (individual medical benefits available at a cost)
The Quality Assurance Project Manager is responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by our plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Compensation is commensurate on level of overall responsibility.
Responsibilities:
- Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of the company) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.
- Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy.
- Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.
- Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.
- Establishes and maintains relationships and open communication with Third Party Manufacturers, plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs a teach site and provide guidance on quality concerns.
- Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide the company with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
- Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
- Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to domestic and International plants for further packaging and/or testing. Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.
- Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
- Bachelor's Degree in relevant Life Science or other technical discipline or equivalent job experience required.
- 7+ years of total combined experience. At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development or Consulting.
- Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
- General quality system experience
- Quality Risk Management
- Production experience, preferably sterile
- Qualification and validation
- Project management
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
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7
QA Project Manager
84043 Lehi, Utah
Vivint
Posted 8 days ago
Job Viewed
Job Description
Welcome to the intersection of energy and home services. At NRG, we're driven by our passion to create a smarter, cleaner and more connected future.
Vivint Smart Home, an NRG owned company, is a leading smart home company in the United States, dedicated to redefining the home experience with intelligent products and services. We find purpose in proactively protecting and keeping our customers connected to home, no matter where they are. Join the Smart Home team to create smarter, safer and more sustainable homes.
**Summary**
Lead projects to identify and resolve issues in a timely and effective way in order to reduce cost to the business and increase customer satisfaction.
**Responsibilities:**
+ Own and drive action plans to resolve quality issues and prevent reoccurrence
+ Report out to leadership and other stakeholders in a way that drives clarity and confidence in team execution
+ Hold team members accountable to completion of assignments
+ Drive metrics and data on quality issues and resolutions to demonstrate results
+ Lead strategic projects to stand up reporting and process to measure and improve quality
+ Thorough and effective communication and documentation
+ Lead prioritization and tradeoff conversations with various stakeholders, including leadership, around software bugs/issues
**Skills / Experience:**
+ Experience defining and implementing quality standards either in a manufacturing, software or other environment
+ Bias for clear communication and documentation, including ability to tailor communication to different audiences
+ Strong executive presence with an ability to work well with senior leadership
+ Comfortable leading a team with a variety of stakeholders and holding them accountable to deliverables
+ Data junkie with a bias for data-driven action
+ A track record of cost savings
+ Six Sigma or other quality training preferred
+ Project management experience preferred
**Education**
+ Bachelor's degree and above
NRG Energy is committed to a drug and alcohol-free workplace. To the extent permitted by law and any applicable collective bargaining agreement, employees are subject to periodic random drug testing, and post-accident and reasonable suspicion drug and alcohol testing. EOE AA M/F/Vet/Disability. Level, Title and/or Salary may be adjusted based on the applicant's experience or skills.
Official description on file with Talent.
Vivint, an equal opportunity employer, does not consider any protected traits (e.g., race, creed, color, religion, gender, national origin, non-job-related disability, age, or any other protected trait) when hiring-under federal, state, and local laws. We are a drug-free environment. We do not conduct pre-employment drug screening; however, we do conduct random drug testing on site.
Vivint Smart Home, an NRG owned company, is a leading smart home company in the United States, dedicated to redefining the home experience with intelligent products and services. We find purpose in proactively protecting and keeping our customers connected to home, no matter where they are. Join the Smart Home team to create smarter, safer and more sustainable homes.
**Summary**
Lead projects to identify and resolve issues in a timely and effective way in order to reduce cost to the business and increase customer satisfaction.
**Responsibilities:**
+ Own and drive action plans to resolve quality issues and prevent reoccurrence
+ Report out to leadership and other stakeholders in a way that drives clarity and confidence in team execution
+ Hold team members accountable to completion of assignments
+ Drive metrics and data on quality issues and resolutions to demonstrate results
+ Lead strategic projects to stand up reporting and process to measure and improve quality
+ Thorough and effective communication and documentation
+ Lead prioritization and tradeoff conversations with various stakeholders, including leadership, around software bugs/issues
**Skills / Experience:**
+ Experience defining and implementing quality standards either in a manufacturing, software or other environment
+ Bias for clear communication and documentation, including ability to tailor communication to different audiences
+ Strong executive presence with an ability to work well with senior leadership
+ Comfortable leading a team with a variety of stakeholders and holding them accountable to deliverables
+ Data junkie with a bias for data-driven action
+ A track record of cost savings
+ Six Sigma or other quality training preferred
+ Project management experience preferred
**Education**
+ Bachelor's degree and above
NRG Energy is committed to a drug and alcohol-free workplace. To the extent permitted by law and any applicable collective bargaining agreement, employees are subject to periodic random drug testing, and post-accident and reasonable suspicion drug and alcohol testing. EOE AA M/F/Vet/Disability. Level, Title and/or Salary may be adjusted based on the applicant's experience or skills.
Official description on file with Talent.
Vivint, an equal opportunity employer, does not consider any protected traits (e.g., race, creed, color, religion, gender, national origin, non-job-related disability, age, or any other protected trait) when hiring-under federal, state, and local laws. We are a drug-free environment. We do not conduct pre-employment drug screening; however, we do conduct random drug testing on site.
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8
QA Project Manager
84043 Lehi, Utah
Vivint
Posted 13 days ago
Job Viewed
Job Description
Welcome to the intersection of energy and home services. At NRG, we're driven by our passion to create a smarter, cleaner and more connected future.
Vivint Smart Home, an NRG owned company, is a leading smart home company in the United States, dedicated to redefining the home experience with intelligent products and services. We find purpose in proactively protecting and keeping our customers connected to home, no matter where they are. Join the Smart Home team to create smarter, safer and more sustainable homes.
**Summary**
Lead projects to identify and resolve issues in a timely and effective way in order to reduce cost to the business and increase customer satisfaction.
**Responsibilities:**
+ Own and drive action plans to resolve quality issues and prevent reoccurrence
+ Report out to leadership and other stakeholders in a way that drives clarity and confidence in team execution
+ Hold team members accountable to completion of assignments
+ Drive metrics and data on quality issues and resolutions to demonstrate results
+ Lead strategic projects to stand up reporting and process to measure and improve quality
+ Thorough and effective communication and documentation
+ Lead prioritization and tradeoff conversations with various stakeholders, including leadership, around software bugs/issues
**Skills / Experience:**
+ Experience defining and implementing quality standards either in a manufacturing, software or other environment
+ Bias for clear communication and documentation, including ability to tailor communication to different audiences
+ Strong executive presence with an ability to work well with senior leadership
+ Comfortable leading a team with a variety of stakeholders and holding them accountable to deliverables
+ Data junkie with a bias for data-driven action
+ A track record of cost savings
+ Six Sigma or other quality training preferred
+ Project management experience preferred
**Education**
+ Bachelor's degree and above
NRG Energy is committed to a drug and alcohol-free workplace. To the extent permitted by law and any applicable collective bargaining agreement, employees are subject to periodic random drug testing, and post-accident and reasonable suspicion drug and alcohol testing. EOE AA M/F/Vet/Disability. Level, Title and/or Salary may be adjusted based on the applicant's experience or skills.
Official description on file with Talent.
Vivint, an equal opportunity employer, does not consider any protected traits (e.g., race, creed, color, religion, gender, national origin, non-job-related disability, age, or any other protected trait) when hiring-under federal, state, and local laws. We are a drug-free environment. We do not conduct pre-employment drug screening; however, we do conduct random drug testing on site.
Vivint Smart Home, an NRG owned company, is a leading smart home company in the United States, dedicated to redefining the home experience with intelligent products and services. We find purpose in proactively protecting and keeping our customers connected to home, no matter where they are. Join the Smart Home team to create smarter, safer and more sustainable homes.
**Summary**
Lead projects to identify and resolve issues in a timely and effective way in order to reduce cost to the business and increase customer satisfaction.
**Responsibilities:**
+ Own and drive action plans to resolve quality issues and prevent reoccurrence
+ Report out to leadership and other stakeholders in a way that drives clarity and confidence in team execution
+ Hold team members accountable to completion of assignments
+ Drive metrics and data on quality issues and resolutions to demonstrate results
+ Lead strategic projects to stand up reporting and process to measure and improve quality
+ Thorough and effective communication and documentation
+ Lead prioritization and tradeoff conversations with various stakeholders, including leadership, around software bugs/issues
**Skills / Experience:**
+ Experience defining and implementing quality standards either in a manufacturing, software or other environment
+ Bias for clear communication and documentation, including ability to tailor communication to different audiences
+ Strong executive presence with an ability to work well with senior leadership
+ Comfortable leading a team with a variety of stakeholders and holding them accountable to deliverables
+ Data junkie with a bias for data-driven action
+ A track record of cost savings
+ Six Sigma or other quality training preferred
+ Project management experience preferred
**Education**
+ Bachelor's degree and above
NRG Energy is committed to a drug and alcohol-free workplace. To the extent permitted by law and any applicable collective bargaining agreement, employees are subject to periodic random drug testing, and post-accident and reasonable suspicion drug and alcohol testing. EOE AA M/F/Vet/Disability. Level, Title and/or Salary may be adjusted based on the applicant's experience or skills.
Official description on file with Talent.
Vivint, an equal opportunity employer, does not consider any protected traits (e.g., race, creed, color, religion, gender, national origin, non-job-related disability, age, or any other protected trait) when hiring-under federal, state, and local laws. We are a drug-free environment. We do not conduct pre-employment drug screening; however, we do conduct random drug testing on site.
View Now
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