6,736 Qa Specialist jobs in the United States
QA Specialist
02454 Waltham, Massachusetts
AbbVie
Posted 1 day ago
Job Viewed
Job Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
This QA Specialist is responsible for reviewing and release of semi-finished, and finished drug product. It also involves ensuring adherence to Standard Operation Procedures and current Good Manufacturing Practices. Quarantine and monitor product on hold and preparing required batch disposition documentation for international sites as required.
-Performing the Quality Assurance review and release of semi-finished product, validation, media, and final products.
-Review batch records to support product release schedule, ensuring regulatory compliance, customer satisfaction and delivery of products.
-Quarantine and monitor product in "on hold" status prior to disposition.
-Prepare required batch disposition documentation and provide to international markets as required to ensure current Good Manufacturing Practices compliance.
-Identify and resolve all batch record discrepancies to prevent a regulatory impact.
-Assist department supervisors in maintaining dispositioned batch records to provide an efficient and secure storage and retrieval process.
-Perform all Final Product and disposition. Following global and SOPs for release in SAP. Exercise independent judgement in every batch based on evidence provided. i.e. CAPAs and their effectiveness
-Performing the Quality Assurance check of all batch related documents for manufacturing, production, validation, and quality assurance departments. Responsible for the final sign-off of the product being release to the market.
-Ability to exercise independent judgement and critical thinking.
Qualifications
-Bachelor's Degree in the Sciences or technical field or equivalent experience.
-5 years of experience in a quality role or experience handling and reviewing documentation records.
-Intermediate Microsoft Word and Microsoft Excel skills. SAP experience preferred.
-3 years of experience in a GMP Environment.
-Prefer experience in an aseptic manufacturing environment.
-Working knowledge of Quality Assurance systems, cGMP's, ISO 13485, CMDRs, and EMEA regulations preferred.
-Competency utilizing Electronic Systems ie. .Maximo and Trackwise. for Quality checks
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
$58,656 - $100,500
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
This QA Specialist is responsible for reviewing and release of semi-finished, and finished drug product. It also involves ensuring adherence to Standard Operation Procedures and current Good Manufacturing Practices. Quarantine and monitor product on hold and preparing required batch disposition documentation for international sites as required.
-Performing the Quality Assurance review and release of semi-finished product, validation, media, and final products.
-Review batch records to support product release schedule, ensuring regulatory compliance, customer satisfaction and delivery of products.
-Quarantine and monitor product in "on hold" status prior to disposition.
-Prepare required batch disposition documentation and provide to international markets as required to ensure current Good Manufacturing Practices compliance.
-Identify and resolve all batch record discrepancies to prevent a regulatory impact.
-Assist department supervisors in maintaining dispositioned batch records to provide an efficient and secure storage and retrieval process.
-Perform all Final Product and disposition. Following global and SOPs for release in SAP. Exercise independent judgement in every batch based on evidence provided. i.e. CAPAs and their effectiveness
-Performing the Quality Assurance check of all batch related documents for manufacturing, production, validation, and quality assurance departments. Responsible for the final sign-off of the product being release to the market.
-Ability to exercise independent judgement and critical thinking.
Qualifications
-Bachelor's Degree in the Sciences or technical field or equivalent experience.
-5 years of experience in a quality role or experience handling and reviewing documentation records.
-Intermediate Microsoft Word and Microsoft Excel skills. SAP experience preferred.
-3 years of experience in a GMP Environment.
-Prefer experience in an aseptic manufacturing environment.
-Working knowledge of Quality Assurance systems, cGMP's, ISO 13485, CMDRs, and EMEA regulations preferred.
-Competency utilizing Electronic Systems ie. .Maximo and Trackwise. for Quality checks
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
$58,656 - $100,500
View Now
0
QA Specialist
02254 Waltham, Massachusetts
BioSpace
Posted 3 days ago
Job Viewed
Job Description
Job Details
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
This QA Specialist is responsible for reviewing and release of semi-finished, and finished drug product. It also involves ensuring adherence to Standard Operation Procedures and current Good Manufacturing Practices. Quarantine and monitor product on hold and preparing required batch disposition documentation for international sites as required.
Performing the Quality Assurance review and release of semi-finished product, validation, media, and final products.
Review batch records to support product release schedule, ensuring regulatory compliance, customer satisfaction and delivery of products.
Quarantine and monitor product in on hold status prior to disposition.
Prepare required batch disposition documentation and provide to international markets as required to ensure current Good Manufacturing Practices compliance.
Identify and resolve all batch record discrepancies to prevent a regulatory impact.
Assist department supervisors in maintaining dispositioned batch records to provide an efficient and secure storage and retrieval process.
Perform all Final Product and disposition. Following global and SOPs for release in SAP. Exercise independent judgement in every batch based on evidence provided. i.e. CAPAs and their effectiveness
Performing the Quality Assurance check of all batch related documents for manufacturing, production, validation, and quality assurance departments. Responsible for the final sign-off of the product being release to the market.
Ability to exercise independent judgement and critical thinking.
Qualifications
Bachelors Degree in the Sciences or technical field or equivalent experience.
5 years of experience in a quality role or experience handling and reviewing documentation records.
Intermediate Microsoft Word and Microsoft Excel skills. SAP experience preferred.
3 years of experience in a GMP Environment.
Prefer experience in an aseptic manufacturing environment.
Working knowledge of Quality Assurance systems, cGMPs, ISO 13485, CMDRs, and EMEA regulations preferred.
Competency utilizing Electronic Systems ie. .Maximo and Trackwise. for Quality checks
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
This QA Specialist is responsible for reviewing and release of semi-finished, and finished drug product. It also involves ensuring adherence to Standard Operation Procedures and current Good Manufacturing Practices. Quarantine and monitor product on hold and preparing required batch disposition documentation for international sites as required.
Performing the Quality Assurance review and release of semi-finished product, validation, media, and final products.
Review batch records to support product release schedule, ensuring regulatory compliance, customer satisfaction and delivery of products.
Quarantine and monitor product in on hold status prior to disposition.
Prepare required batch disposition documentation and provide to international markets as required to ensure current Good Manufacturing Practices compliance.
Identify and resolve all batch record discrepancies to prevent a regulatory impact.
Assist department supervisors in maintaining dispositioned batch records to provide an efficient and secure storage and retrieval process.
Perform all Final Product and disposition. Following global and SOPs for release in SAP. Exercise independent judgement in every batch based on evidence provided. i.e. CAPAs and their effectiveness
Performing the Quality Assurance check of all batch related documents for manufacturing, production, validation, and quality assurance departments. Responsible for the final sign-off of the product being release to the market.
Ability to exercise independent judgement and critical thinking.
Qualifications
Bachelors Degree in the Sciences or technical field or equivalent experience.
5 years of experience in a quality role or experience handling and reviewing documentation records.
Intermediate Microsoft Word and Microsoft Excel skills. SAP experience preferred.
3 years of experience in a GMP Environment.
Prefer experience in an aseptic manufacturing environment.
Working knowledge of Quality Assurance systems, cGMPs, ISO 13485, CMDRs, and EMEA regulations preferred.
Competency utilizing Electronic Systems ie. .Maximo and Trackwise. for Quality checks
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
View Now
1
QA Specialist
27540 Holly Springs, North Carolina
BioSpace
Posted 4 days ago
Job Viewed
Job Description
Job Details
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
QA Specialist
What you will do
Lets do this! Lets change the world!
In this vital role the specialist will leverage industry, technical, and quality systems knowledge to perform a comprehensive review of product manufacturing elements and execute a quality-critical disposition decision ensuring that batches are appropriately controlled.
The disposition specialist will lead and coordinate timely release of raw material product batches from assigned plants to ensure uninterrupted patient supply. The staff member will regularly present disposition status and metrics in a cross-functional leadership setting and proactively escalate supply interrupters. The individual will support waste reduction and patient supply at the site through leadership of and/or participation in continuous improvement initiatives.
Amgen teams
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications.
Basic Qualifications:
Preferred Qualifications:
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
QA Specialist
What you will do
Lets do this! Lets change the world!
In this vital role the specialist will leverage industry, technical, and quality systems knowledge to perform a comprehensive review of product manufacturing elements and execute a quality-critical disposition decision ensuring that batches are appropriately controlled.
The disposition specialist will lead and coordinate timely release of raw material product batches from assigned plants to ensure uninterrupted patient supply. The staff member will regularly present disposition status and metrics in a cross-functional leadership setting and proactively escalate supply interrupters. The individual will support waste reduction and patient supply at the site through leadership of and/or participation in continuous improvement initiatives.
- Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
- Execute the Raw Material and Product disposition process as required per standard operating procedure.
- Compilation and presentation of disposition metrics and status
- Provide change control record quality assessments ensuring adherence to procedural requirements and regulatory expectations.
- Support of internal audits
- Direct interaction with regulatory agencies during on-site inspections
- Provides quality expertise and guidance to operational staff and within cross functional
Amgen teams
- Drive implementation of Quality Systems in compliance to Amgen Standards and Regulatory expectations.
- Review and approves controlled documents
- Attain ERP/SAP system proficiency
- Expiration extensions
- Country Cluster Modifications
- Annual Product Review data verification/quality approval
- Import Documentation Requests
- Product / Material Transfers
- Ensure that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls Contribute to and drive continuous improvement projects in cross-functional collaboration.
- Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
- Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications.
Basic Qualifications:
- High school diploma / GED and 10 years of Quality or Operations experience OR
- Associates degree and 8 years of Quality or Operations experience OR
- Bachelors degree and 4 years of Quality or Operations experience OR
- Masters degree and 2 years of Quality or Operations experience OR
- Doctorate degree
Preferred Qualifications:
- Educational background in a science field
- Experience with Quality Management Systems
- Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
- Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues
- Knowledge of operations business processes, manufacturing processes and/or materials management
- Demonstrated ability in problem solving
- Experience working with dynamic cross-functional teams and demonstrated abilities in decision making
- Strong organizational skills, including ability to follow assignments through to completion
- Proficiency with Document Control, Change Controls, Exceptions Management
- Previous disposition experience supporting raw materials and/or product
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
View Now
2
QA Specialist
27540 Holly Springs, North Carolina
Amgen
Posted 4 days ago
Job Viewed
Job Description
**Join Amgen's Mission of Serving Patients**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**QA Specialist**
**What you will do**
Let's do this! Let's change the world!
In this vital role the specialist will leverage industry, technical, and quality systems knowledge to perform a comprehensive review of product manufacturing elements and execute a quality-critical disposition decision ensuring that batches are appropriately controlled.
The disposition specialist will lead and coordinate timely release of raw material product batches from assigned plants to ensure uninterrupted patient supply. The staff member will regularly present disposition status and metrics in a cross-functional leadership setting and proactively escalate supply interrupters. The individual will support waste reduction and patient supply at the site through leadership of and/or participation in continuous improvement initiatives.
+ Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
+ Execute the Raw Material and Product disposition process as required per standard operating procedure.
+ Compilation and presentation of disposition metrics and status
+ Provide change control record quality assessments ensuring adherence to procedural requirements and regulatory expectations.
+ Support of internal audits
+ Direct interaction with regulatory agencies during on-site inspections
+ Provides quality expertise and guidance to operational staff and within cross functional
**Amgen teams**
+ Drive implementation of Quality Systems in compliance to Amgen Standards and Regulatory expectations.
+ Review and approves controlled documents
+ Attain ERP/SAP system proficiency
+ Expiration extensions
+ Country Cluster Modifications
+ Annual Product Review data verification/quality approval
+ Import Documentation Requests
+ Product / Material Transfers
+ Ensure that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls Contribute to and drive continuous improvement projects in cross-functional collaboration.
+ Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
+ Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 10 years of Quality or Operations experience OR
+ Associate's degree and 8 years of Quality or Operations experience OR
+ Bachelor's degree and 4 years of Quality or Operations experience OR
+ Master's degree and 2 years of Quality or Operations experience OR
+ Doctorate degree
**Preferred Qualifications:**
+ Educational background in a science field
+ Experience with Quality Management Systems
+ Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
+ Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues
+ Knowledge of operations business processes, manufacturing processes and/or materials management
+ Demonstrated ability in problem solving
+ Experience working with dynamic cross-functional teams and demonstrated abilities in decision making
+ Strong organizational skills, including ability to follow assignments through to completion
+ Proficiency with Document Control, Change Controls, Exceptions Management
+ Previous disposition experience supporting raw materials and/or product
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**QA Specialist**
**What you will do**
Let's do this! Let's change the world!
In this vital role the specialist will leverage industry, technical, and quality systems knowledge to perform a comprehensive review of product manufacturing elements and execute a quality-critical disposition decision ensuring that batches are appropriately controlled.
The disposition specialist will lead and coordinate timely release of raw material product batches from assigned plants to ensure uninterrupted patient supply. The staff member will regularly present disposition status and metrics in a cross-functional leadership setting and proactively escalate supply interrupters. The individual will support waste reduction and patient supply at the site through leadership of and/or participation in continuous improvement initiatives.
+ Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety and ensure we continue to meet Amgen standards.
+ Execute the Raw Material and Product disposition process as required per standard operating procedure.
+ Compilation and presentation of disposition metrics and status
+ Provide change control record quality assessments ensuring adherence to procedural requirements and regulatory expectations.
+ Support of internal audits
+ Direct interaction with regulatory agencies during on-site inspections
+ Provides quality expertise and guidance to operational staff and within cross functional
**Amgen teams**
+ Drive implementation of Quality Systems in compliance to Amgen Standards and Regulatory expectations.
+ Review and approves controlled documents
+ Attain ERP/SAP system proficiency
+ Expiration extensions
+ Country Cluster Modifications
+ Annual Product Review data verification/quality approval
+ Import Documentation Requests
+ Product / Material Transfers
+ Ensure that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls Contribute to and drive continuous improvement projects in cross-functional collaboration.
+ Represent the Quality function and provide quality oversight during the implementation of projects required to improve and deliver our departmental and manufacturing plant goals.
+ Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications.
**Basic Qualifications:**
+ High school diploma / GED and 10 years of Quality or Operations experience OR
+ Associate's degree and 8 years of Quality or Operations experience OR
+ Bachelor's degree and 4 years of Quality or Operations experience OR
+ Master's degree and 2 years of Quality or Operations experience OR
+ Doctorate degree
**Preferred Qualifications:**
+ Educational background in a science field
+ Experience with Quality Management Systems
+ Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
+ Ability to complete tasks autonomously, problem solve and provide updates to senior management, and identifying potential issues
+ Knowledge of operations business processes, manufacturing processes and/or materials management
+ Demonstrated ability in problem solving
+ Experience working with dynamic cross-functional teams and demonstrated abilities in decision making
+ Strong organizational skills, including ability to follow assignments through to completion
+ Proficiency with Document Control, Change Controls, Exceptions Management
+ Previous disposition experience supporting raw materials and/or product
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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3
QA Specialist
07920 Basking Ridge, New Jersey
Actalent
Posted 5 days ago
Job Viewed
Job Description
Job Title: QA Regulatory Affairs Specialist
Job Description
This position requires reviewing label content to ensure accuracy, consistency, and compliance. The role involves using labeling software to prepare and submit SPL, collaborating with customers for private labeling, and communicating labeling requirements and timelines to internal stakeholders.
Responsibilities
+ Coordinate label approvals and manage version controls and updated labeling.
+ Support change control processes related to labeling updates.
+ Coordinate labeling projects to ensure regulatory compliance.
+ Facilitate project completion through effective and detailed project management.
+ Provide guidance to team members on labeling regulations and process requirements.
+ Initiate, review, and implement label creation/updates with extreme attention to detail.
+ Identify and recommend process improvements to enhance business practices.
+ Provide regular updates regarding labeling projects to cross-functional departments.
+ Foster collaborative, efficient, and effective working relationships with internal teams.
+ Prepare and submit Annual Reports.
+ Mentor team members and act as a recognized resource to local team.
+ Perform other duties as assigned based on business requirements.
Essential Skills
+ Quality assurance expertise.
+ Knowledge of FDA regulations.
+ Understanding of SOPs.
+ Ability to partner with members across departments like Regulatory and Quality to ensure compliance.
+ Proficient knowledge of GMP and Quality Management Systems.
+ Computer literacy in Windows applications and MS Office (Word, Excel, Outlook).
Additional Skills & Qualifications
+ A minimum of a BS in a scientific discipline.
+ 1-3 years of experience in pharmaceutical manufacturing.
+ 1-2 years of quality experience with pharmaceutical FDA submissions.
Work Environment
This role operates within a GMP environment on the QA team, offering room for growth. The position requires collaboration with teams based both in the US and India.
Pay and Benefits
The pay range for this position is $8000.00 - $87000.00/yr.
401k is really great! We offer 3% contribution regardless of contribution and offer an additional match up to 1.5%. So if they contribute 1.5% they get 6% toward 401k.
Workplace Type
This is a fully onsite position in Basking Ridge,NJ.
Application Deadline
This position is anticipated to close on Aug 29, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
Job Description
This position requires reviewing label content to ensure accuracy, consistency, and compliance. The role involves using labeling software to prepare and submit SPL, collaborating with customers for private labeling, and communicating labeling requirements and timelines to internal stakeholders.
Responsibilities
+ Coordinate label approvals and manage version controls and updated labeling.
+ Support change control processes related to labeling updates.
+ Coordinate labeling projects to ensure regulatory compliance.
+ Facilitate project completion through effective and detailed project management.
+ Provide guidance to team members on labeling regulations and process requirements.
+ Initiate, review, and implement label creation/updates with extreme attention to detail.
+ Identify and recommend process improvements to enhance business practices.
+ Provide regular updates regarding labeling projects to cross-functional departments.
+ Foster collaborative, efficient, and effective working relationships with internal teams.
+ Prepare and submit Annual Reports.
+ Mentor team members and act as a recognized resource to local team.
+ Perform other duties as assigned based on business requirements.
Essential Skills
+ Quality assurance expertise.
+ Knowledge of FDA regulations.
+ Understanding of SOPs.
+ Ability to partner with members across departments like Regulatory and Quality to ensure compliance.
+ Proficient knowledge of GMP and Quality Management Systems.
+ Computer literacy in Windows applications and MS Office (Word, Excel, Outlook).
Additional Skills & Qualifications
+ A minimum of a BS in a scientific discipline.
+ 1-3 years of experience in pharmaceutical manufacturing.
+ 1-2 years of quality experience with pharmaceutical FDA submissions.
Work Environment
This role operates within a GMP environment on the QA team, offering room for growth. The position requires collaboration with teams based both in the US and India.
Pay and Benefits
The pay range for this position is $8000.00 - $87000.00/yr.
401k is really great! We offer 3% contribution regardless of contribution and offer an additional match up to 1.5%. So if they contribute 1.5% they get 6% toward 401k.
Workplace Type
This is a fully onsite position in Basking Ridge,NJ.
Application Deadline
This position is anticipated to close on Aug 29, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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4
QA Specialist
27518, North Carolina
Epic Games
Posted 7 days ago
Job Viewed
Job Description
WHAT MAKES US EPIC?
At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually stunning interactive experiences, we're always innovating.
Being Epic means being a part of a team that continually strives to do right by our community and users. We're constantly innovating to raise the bar of engine and game development.
QUALITY ASSURANCE
What makes us Epic?
At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually stunning interactive experiences, we're always innovating.
Being Epic means being a part of a team that continually strives to do right by our community and users. We're constantly innovating to raise the bar of engine and game development.
What we do
We're looking for a QA Specialist within the Social Overlay team to help us make the future of our products strong! You will work to develop and implement test plans, execute testing, and utilize tooling to expand the breadth and depth of our QA coverage in a dynamic and fast-paced environment. As a QA Specialist, you will also help to support the team's efforts around testing approach, execution, and risk assessment.
What You'll Do
As a QA Specialist, you will work directly with our designers, engineers, producers, etc., on a regular basis. You will develop and implement test plans, execute testing, and utilize tooling to expand the breadth and depth of our QA coverage. We are looking for a teammate who is passionate about testing and will be responsible for owning the test process, risk management, and quality evaluation of the project features. You are expected to work closely with other team members and vendors on a daily basis.
In this role, you will
* Work with QA Analysts, QA Engineers, QA leadership, SDETs, product owners, and developers to define acceptance criteria, identify risks, plan test coverage, and execute against the plans.
* Build and drive test strategies and test plans to cover multiple features in a dynamic and fast-paced environment.
* Examine gaps in test plan and approach, collaborating with geographically distributed teams to deliver the highest quality version of the product, possible.
* Coordinate functional, qualitative, and performance testing efforts.
* Use a mix of manual and technical testing skills to execute a variety of testing techniques across the product.
* Analyze the quality of the product while troubleshooting reported defects and internal issues.
* Track and Report on quality data and use that data to drive conversations around product quality and development health.
* Verify fixes are implemented correctly throughout the product life cycle.
* Effective and on-time completion of related test documentation.
What we're looking for
* 5+ years of web software testing experience in a fast-paced environment with an ability to juggle multiple projects
* Experience working embedded in SDLC
* Expertise in creating/modifying end-to-end test plans of high complexity across multiple iterations/development cycles
* Experience utilizing Xcode for iOS and ADB for Android - for native mobile application development and testing. Including tools utilized for over-the-air installations - such as Android Debug Bridge or Google Play Console and TestFlight
* Experience testing and debugging native builds for gaming consoles - Playstation, Xbox, Switch, etc.,
* Past experience testing web-based features for frontend and backend services and creating detailed test plans and test cases
* Experience using tools such as Charles, Android Debug Bridge, and other testing tools to help facilitate troubleshooting and testing
* Problem-solving experience especially in technical environments utilizing debugging tools to investigate and report on results (Chrome Debug tools, Firebug etc)
* Solid understanding of test methodologies, including automation, functional, qualitative, and performance against consistently iterative development
* Strong communication skills and ability to confidently collaborate with senior dev engineers for day-to-day testing requirements and collaboration.
EPIC JOB + EPIC BENEFITS = EPIC LIFE
Our intent is to cover all things that are medically necessary and improve the quality of life. We pay 100% of the premiums for both you and your dependents. Our coverage includes Medical, Dental, a Vision HRA, Long Term Disability, Life Insurance & a 401k with competitive match. We also offer a robust mental well-being program through Modern Health, which provides free therapy and coaching for employees & dependents. Throughout the year we celebrate our employees with events and company-wide paid breaks. We offer unlimited PTO and sick time and recognize individuals for 7 years of employment with a paid sabbatical.
ABOUT US
Epic Games spans across 25 countries with 46 studios and 4,500+ employees globally. For over 25 years, we've been making award-winning games and engine technology that empowers others to make visually stunning games and 3D content that bring environments to life like never before. Epic's award-winning Unreal Engine technology not only provides game developers the ability to build high-fidelity, interactive experiences for PC, console, mobile, and VR, it is also a tool being embraced by content creators across a variety of industries such as media and entertainment, automotive, and architectural design. As we continue to build our Engine technology and develop remarkable games, we strive to build teams of world-class talent.
Like what you hear? Come be a part of something Epic!
Epic Games deeply values diverse teams and an inclusive work culture, and we are proud to be an Equal Opportunity employer. Learn more about our Equal Employment Opportunity (EEO) Policy here.
Note to Recruitment Agencies: Epic does not accept any unsolicited resumes or approaches from any unauthorized third party (including recruitment or placement agencies) (i.e., a third party with whom we do not have a negotiated and validly executed agreement). We will not pay any fees to any unauthorized third party. Further details on these matters can be found here.
At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually stunning interactive experiences, we're always innovating.
Being Epic means being a part of a team that continually strives to do right by our community and users. We're constantly innovating to raise the bar of engine and game development.
QUALITY ASSURANCE
What makes us Epic?
At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually stunning interactive experiences, we're always innovating.
Being Epic means being a part of a team that continually strives to do right by our community and users. We're constantly innovating to raise the bar of engine and game development.
What we do
We're looking for a QA Specialist within the Social Overlay team to help us make the future of our products strong! You will work to develop and implement test plans, execute testing, and utilize tooling to expand the breadth and depth of our QA coverage in a dynamic and fast-paced environment. As a QA Specialist, you will also help to support the team's efforts around testing approach, execution, and risk assessment.
What You'll Do
As a QA Specialist, you will work directly with our designers, engineers, producers, etc., on a regular basis. You will develop and implement test plans, execute testing, and utilize tooling to expand the breadth and depth of our QA coverage. We are looking for a teammate who is passionate about testing and will be responsible for owning the test process, risk management, and quality evaluation of the project features. You are expected to work closely with other team members and vendors on a daily basis.
In this role, you will
* Work with QA Analysts, QA Engineers, QA leadership, SDETs, product owners, and developers to define acceptance criteria, identify risks, plan test coverage, and execute against the plans.
* Build and drive test strategies and test plans to cover multiple features in a dynamic and fast-paced environment.
* Examine gaps in test plan and approach, collaborating with geographically distributed teams to deliver the highest quality version of the product, possible.
* Coordinate functional, qualitative, and performance testing efforts.
* Use a mix of manual and technical testing skills to execute a variety of testing techniques across the product.
* Analyze the quality of the product while troubleshooting reported defects and internal issues.
* Track and Report on quality data and use that data to drive conversations around product quality and development health.
* Verify fixes are implemented correctly throughout the product life cycle.
* Effective and on-time completion of related test documentation.
What we're looking for
* 5+ years of web software testing experience in a fast-paced environment with an ability to juggle multiple projects
* Experience working embedded in SDLC
* Expertise in creating/modifying end-to-end test plans of high complexity across multiple iterations/development cycles
* Experience utilizing Xcode for iOS and ADB for Android - for native mobile application development and testing. Including tools utilized for over-the-air installations - such as Android Debug Bridge or Google Play Console and TestFlight
* Experience testing and debugging native builds for gaming consoles - Playstation, Xbox, Switch, etc.,
* Past experience testing web-based features for frontend and backend services and creating detailed test plans and test cases
* Experience using tools such as Charles, Android Debug Bridge, and other testing tools to help facilitate troubleshooting and testing
* Problem-solving experience especially in technical environments utilizing debugging tools to investigate and report on results (Chrome Debug tools, Firebug etc)
* Solid understanding of test methodologies, including automation, functional, qualitative, and performance against consistently iterative development
* Strong communication skills and ability to confidently collaborate with senior dev engineers for day-to-day testing requirements and collaboration.
EPIC JOB + EPIC BENEFITS = EPIC LIFE
Our intent is to cover all things that are medically necessary and improve the quality of life. We pay 100% of the premiums for both you and your dependents. Our coverage includes Medical, Dental, a Vision HRA, Long Term Disability, Life Insurance & a 401k with competitive match. We also offer a robust mental well-being program through Modern Health, which provides free therapy and coaching for employees & dependents. Throughout the year we celebrate our employees with events and company-wide paid breaks. We offer unlimited PTO and sick time and recognize individuals for 7 years of employment with a paid sabbatical.
ABOUT US
Epic Games spans across 25 countries with 46 studios and 4,500+ employees globally. For over 25 years, we've been making award-winning games and engine technology that empowers others to make visually stunning games and 3D content that bring environments to life like never before. Epic's award-winning Unreal Engine technology not only provides game developers the ability to build high-fidelity, interactive experiences for PC, console, mobile, and VR, it is also a tool being embraced by content creators across a variety of industries such as media and entertainment, automotive, and architectural design. As we continue to build our Engine technology and develop remarkable games, we strive to build teams of world-class talent.
Like what you hear? Come be a part of something Epic!
Epic Games deeply values diverse teams and an inclusive work culture, and we are proud to be an Equal Opportunity employer. Learn more about our Equal Employment Opportunity (EEO) Policy here.
Note to Recruitment Agencies: Epic does not accept any unsolicited resumes or approaches from any unauthorized third party (including recruitment or placement agencies) (i.e., a third party with whom we do not have a negotiated and validly executed agreement). We will not pay any fees to any unauthorized third party. Further details on these matters can be found here.
View Now
5
QA Specialist
02154 Waltham, Massachusetts
Cambrex
Posted 7 days ago
Job Viewed
Job Description
Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! About Snapdragon Chemistry Snapdragon Chemistry was acquired by Cambrex in 2023 due to its innovative approach to chemical development and is now fully integrated into Cambrex. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in process development and advanced continuous manufacturing technology for traditional small molecules and complex-synthetics. At Snapdragon Chemistry, we strive to create an environment of innovation and excellence where mutual respect and teamwork underpin our culture. Snapdragon Chemistry, Inc. is a leader in chemical process development with expertise in continuous flow and process intensification technologies. Our company is catalyzing the transformation of research, development, and manufacturing across the pharmaceutical and fine chemical industries where synthetic chemistry underpins product development. We rely on our most valuable resource - our people - to maintain a leadership position in this market. As part of our dynamic team, you will have the opportunity to collaborate with world-class leaders in pharmaceutical process development while also cultivating and furthering your career. Job Overview Snapdragon Chemistry is currently seeking exceptional candidates for its Quality Assurance Specialist position. A successful candidate, reporting to the Quality Assurance Manager, will be joining a highly innovative and entrepreneurial team of engineers and scientists seeking to advance pharmaceutical development and manufacturing. The QA Specialist will play a key role in supporting Snapdragon Chemistry's Quality Management System (QMS) and GMP operations. This role involves oversight of document control, training compliance, equipment lifecycle documentation, batch record review, lot disposition, and ongoing support for manufacturing and quality initiatives. The ideal candidate will ensure GMP standards are upheld across all stages of production and documentation. We are looking for candidates who have a passion for the science of pharmaceutical manufacturing and excited to share the Snapdragon vision of future manufacturing. The ideal candidate will have at minimum a BS degree in scientific discipline and pharmaceutical quality assurance experience. Responsibilities Support the Quality Assurance function at Snapdragon Chemistry, a Cambrex company, to ensure compliance with cGMP and internal quality standards. Maintain and manage the Quality Management System (QMS) to meet regulatory and internal procedural requirements. Support document control activities including issuance, revision control, archival, and retirement of controlled documents. Oversee the training management system by ensuring training assignments are current and tracked for all applicable personnel. Assist with equipment lifecycle management, including initiation, qualification, and periodic review of equipment. Generate periodic reports and trend quality system data to support audits, inspections, and management reviews. Coordinate issuance of lot numbers and Master Batch Records (MBRs) to support GMP manufacturing activities. Review raw material documentation, batch records, and analytical data to ensure compliance and completeness. Perform lot disposition activities, including review and reconciliation of batch records, deviations, investigations, out-of-specification (OOS) reports, and preparation of final QA disposition documentation for client delivery. Facilitate release of manufacturing suites both pre- and post-cleaning for GMP operations. Coordinate in-process GMP document reviews with clients and manage client approval workflows. Interface with clients during audits, document reviews, and to address quality-related questions during project execution. Manage laboratory notebook lifecycle, including issuance, tracking, collection, auditing, and archival. Ensure compliance with data integrity principles (ALCOA) in lab documentation practices. Support execution of client and vendor qualification programs, including coordination of qualification documentation and audit activities. Assist with internal and external audit preparation, document retrieval, and audit responses. Participate in continuous improvement initiatives focused on enhancing quality systems and operational workflows. Assist with onboarding and QA training for new personnel. Perform other QA-related duties as assigned by QA leadership. Qualifications/Skills 1-3 years QA experience including managing GMP quality systems in the Pharma/Biotech industry. Knowledge of cGMP requirements for small molecule development and manufacturing a plus. Experience with industry Quality Management System (QMS) software. Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines. Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively. Education, Experience & Licensing Requirements BS degree in a scientific discipline Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-SK1BS degree in a scientific disciplineSupport the Quality Assurance function at Snapdragon Chemistry, a Cambrex company, to ensure compliance with cGMP and internal quality standards. Maintain and manage the Quality Management System (QMS) to meet regulatory and internal procedural requirements. Support document control activities including issuance, revision control, archival, and retirement of controlled documents. Oversee the training management system by ensuring training assignments are current and tracked for all applicable personnel. Assist with equipment lifecycle management, including initiation, qualification, and periodic review of equipment. Generate periodic reports and trend quality system data to support audits, inspections, and management reviews. Coordinate issuance of lot numbers and Master Batch Records (MBRs) to support GMP manufacturing activities. Review raw material documentation, batch records, and analytical data to ensure compliance and completeness. Perform lot disposition activities, including review and reconciliation of batch records, deviations, investigations, out-of-specification (OOS) reports, and preparation of final QA disposition documentation for client delivery. Facilitate release of manufacturing suites both pre- and post-cleaning for GMP operations. Coordinate in-process GMP document reviews with clients and manage client approval workflows. Interface with clients during audits, document reviews, and to address quality-related questions during project execution. Manage laboratory notebook lifecycle, including issuance, tracking, collection, auditing, and archival. Ensure compliance with data integrity principles (ALCOA) in lab documentation practices. Support execution of client and vendor qualification programs, including coordination of qualification documentation and audit activities. Assist with internal and external audit preparation, document retrieval, and audit responses. Participate in continuous improvement initiatives focused on enhancing quality systems and operational workflows. Assist with onboarding and QA training for new personnel. Perform other QA-related duties as assigned by QA leadership.
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6
QA Specialist
53597 Waunakee, Wisconsin
Actalent
Posted 7 days ago
Job Viewed
Job Description
Quality Assurance Specialist3rd Shift Only
Job Description
The Quality Assurance Specialist will spend the majority of their time on the production floor, assisting the operations team with verifications, conducting general walkthroughs, performing onsite reviews, and executing mini-audits to ensure compliance. They will also be responsible for identifying solutions to problems, such as initiating deviations. Document review, including executed batch records, cleaning records, and logbooks, as well as issuing batch records when necessary, is also part of this role. Approximately 80-85% of the time will be spent on the floor, with the remainder in the office. Gowning requirements vary from safety shoes to full protective gear, depending on the area.
Responsibilities
+ Assist the operations team with verifications and general walkthroughs.
+ Perform onsite reviews and mini-audits to ensure compliance.
+ Identify solutions to problems, such as initiating deviations.
+ Review documents, including executed batch records, cleaning records, and logbooks.
+ Issue batch records as needed.
Essential Skills
+ Quality assurance expertise.
+ Experience with FDA regulations.
+ Batch record and CAPA (Corrective and Preventive Action) management.
+ Audit and document control skills.
+ Pharmaceutical industry knowledge.
Additional Skills & Qualifications
+ Bachelor's degree in any science discipline preferred.
+ 2+ years of experience in a regulated industry (GMP/FDA/ISO) for specialists.
+ 5+ years of experience in a regulated industry for Sr. positions.
+ 7+ years of experience in a regulated industry for lead positions.
+ Experience supervising direct reports or leading teams is a plus.
Work Environment
The role involves working primarily on the production floor, with some time spent in an office environment. Employees work on nights (4pm to 4am) with a rotating schedule of 3 days on, 2 days off, 2 days on, and 3 days off. Training is conducted on the first shift, Monday to Friday, from 8 am to 4:30 pm for 6-8 weeks. Employees must adhere to varying gowning requirements, from safety shoes to full protective gear, depending on the area.
Pay and Benefits
The pay range for this position is $62000.00 - $9000.00/yr.
Medical, dental, 401K, vision
Workplace Type
This is a fully onsite position in Waunakee,WI.
Application Deadline
This position is anticipated to close on Aug 22, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
Job Description
The Quality Assurance Specialist will spend the majority of their time on the production floor, assisting the operations team with verifications, conducting general walkthroughs, performing onsite reviews, and executing mini-audits to ensure compliance. They will also be responsible for identifying solutions to problems, such as initiating deviations. Document review, including executed batch records, cleaning records, and logbooks, as well as issuing batch records when necessary, is also part of this role. Approximately 80-85% of the time will be spent on the floor, with the remainder in the office. Gowning requirements vary from safety shoes to full protective gear, depending on the area.
Responsibilities
+ Assist the operations team with verifications and general walkthroughs.
+ Perform onsite reviews and mini-audits to ensure compliance.
+ Identify solutions to problems, such as initiating deviations.
+ Review documents, including executed batch records, cleaning records, and logbooks.
+ Issue batch records as needed.
Essential Skills
+ Quality assurance expertise.
+ Experience with FDA regulations.
+ Batch record and CAPA (Corrective and Preventive Action) management.
+ Audit and document control skills.
+ Pharmaceutical industry knowledge.
Additional Skills & Qualifications
+ Bachelor's degree in any science discipline preferred.
+ 2+ years of experience in a regulated industry (GMP/FDA/ISO) for specialists.
+ 5+ years of experience in a regulated industry for Sr. positions.
+ 7+ years of experience in a regulated industry for lead positions.
+ Experience supervising direct reports or leading teams is a plus.
Work Environment
The role involves working primarily on the production floor, with some time spent in an office environment. Employees work on nights (4pm to 4am) with a rotating schedule of 3 days on, 2 days off, 2 days on, and 3 days off. Training is conducted on the first shift, Monday to Friday, from 8 am to 4:30 pm for 6-8 weeks. Employees must adhere to varying gowning requirements, from safety shoes to full protective gear, depending on the area.
Pay and Benefits
The pay range for this position is $62000.00 - $9000.00/yr.
Medical, dental, 401K, vision
Workplace Type
This is a fully onsite position in Waunakee,WI.
Application Deadline
This position is anticipated to close on Aug 22, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
View Now
7
QA Specialist
60077 Skokie, Illinois
Johnson Service Group
Posted 7 days ago
Job Viewed
Job Description
Job Description
QA Specialist
JSG is a professional search firm, seeking a detail-oriented QA Specialist to help ensure that our Clients products meet the highest standards of food safety and quality.
What You'll Do
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
QA Specialist
JSG is a professional search firm, seeking a detail-oriented QA Specialist to help ensure that our Clients products meet the highest standards of food safety and quality.
What You'll Do
- Conduct in-process quality inspections across all production lines
- Verify product labels, lot codes, weights, and allergen controls
- Review and approve HACCP and metal detection documentation
- Manage product holds and document all related actions
- Assist in root cause investigations and corrective actions (CAPA)
- Monitor GMP compliance and issue daily reports
- Perform swabbing and sanitation validations
- Support customer and certification audits
- Train new QA staff and serve as backup for other QA roles
- High school diploma required; college coursework a plus
- 1+ year of experience in QA/QC or food manufacturing
- HACCP certification (3rd-party)
- Strong attention to detail and organizational skills
- Good written and verbal communication skills
- Ability to multitask in a fast-paced environment
- GMP, Allergen, and Food Safety Training
- HACCP and Company Policy Training
- Ongoing support for professional growth
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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