4 Building Surveyor jobs in the United States
Director - Manufacturing Site Inspection Management, Quality
Posted 7 days ago
Job Viewed
Job Description
General/Position Summary
The Director, CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site for Cell & Gene. This role will be responsible for the development of an inspection program for site compliance and maturity, inspection preparation, consistent state of readiness and inspection management. The role is responsible for designing the program, identifying risks, driving mitigation of such risks and supporting cross-functional partners in ensuring execution.
Additional responsibilities include support for external site inspection readiness. Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone with significant experience in establishing manufacturing site inspection programs from development to commercial and successfully executing to maintain a constant inspection readiness site.
This is a Cell & Gene manufacturing site based role located in the Boston Seaport.
Key Duties & Responsibilities
* Serves as manufacturing site CMC Inspection Lead with responsibility for the overall strategic direction, oversight, performance and effectiveness of the site inspection program.
* Responsible for identification of compliance gaps/risks, drives alignment on mitigation and assures action execution to closure.
* Develops and implements strategies for inspection readiness, including mock inspections, training, and site preparation visits.
* Partners with the site QA leadership and cross-functional leadership for coordination and alignment in ensuring overall execution, readiness and site maturity adequacy.
* Collaborating with cross-functional teams to develop and implement effective corrective and preventive actions (CAPAs) in response to audit and inspection findings.
* Collaborates with the Global Quality Audit and Inspection Management to enable execution and maturity of site for pre-approval inspection and other inspection readiness.
* Monitoring and analyzing key performance indicators (KPIs) related to internal audits, inspections and compliance, and identifying areas for improvement.
* Communicates status, risks, and escalations with management through governance forums and ongoing report outs.
* Leads/Engages/Support in Quality projects ensure successful planning, execution and on-time delivery.
* Ensure activities and deliverables are in compliance with Global HA regulations, Vertex SOPs and industry best practices.
* Provides functional area leadership and management through the execution of Goals, Employee learning and development, and budget forecasting.
Required Education Level
Bachelor's degree in a Scientific/Engineering/Lifesciences field.
Required Experience
Typically requires 12+ years of relevant industry experience in a commercial manufacturing site in biotechnology/regulated pharmaceutical environment.
Required Knowledge/Skills
* In-depth GxP experience with current knowledge of industry trends, HA regulations & expectations, and best practices
* Extensive knowledge of commercial readiness, with inspection planning/coordination and management for regulatory authority inspections at a manufacturing site
* Broad knowledge of Cell & Gene therapy and/or Biologics, aseptic manufacturing processing.
* Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
* Strong leadership skills with the ability to organize and execute tasks effectively.
* Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
* Ability to apply risk management principles to decision making and operational priorities.
* Ability to manage multiple projects, work in a dynamic environment and communicate effectively with senior leaders.
Other Requirements
5% travel may be required.
#LI-onsite
Pay Range:
$176,000 - $264,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site Designated
Flex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at
Part Time Site Inspection Representative - Rochester, MN
Posted 24 days ago
Job Viewed
Job Description
The CSI Companies is actively searching for outgoing candidates with in-person customer service experience to fill several Site Inspection Representative roles with a high-profile company in Rochester, MN. This is a long-term contract opportunity expected to be a year or more. Schedule: The hours per week are based upon the number of surveys in a Contractor's area but will be during normal business hours, Mon-Fri 8am-5pm. May be part time and should not exceed 40 hours. Contractor to be utilized on an as needed basis based on the client's issuance of locations to be visited. About the job: This is a COVID-conscious role with limited interaction that requires commuting to different healthcare facilities to conduct fieldwork (surveys, site visits, verifications, etc) by using a company-provided application on one's personal smartphone. Site visits will be either observational or detailed in nature. Observational site visits will entail minimal contact with staff or customers, photos will be taken and a report will be filed. Detailed site visits will be more time consuming and will require contact with staff to conduct a basic interview, take photos and file a report. The goal of site visits is to confirm outlined operation and/or compliance related information. Contractors will be expected to maintain a low profile and strict confidentiality. Candidates within this role will have the opportunity to manage their own schedule, travel in safety and conduct surveys in order to validate the legitimacy of medical sites. This position offers:
- Competitive compensation for hours worked
- The opportunity to master inspection strategies and techniques within a long-term contract
- Schedule flexibility due to autonomous out-of-office workload
- Limited in-person interaction on sites
- Expedited digital new-hire onboarding process
- A positive company culture and room to grow!
- High school degree or GED at minimum
- Completion of a 2-4 hours virtual training course
- Personal transportation to commute to and from sites located within a 50-mile radius
- Ownership of a smartphone with reliable camera quality for relevant survey documentation
- Ability to learn and navigate company application (training provided)
- Willingness to travel to various sites to conduct up to two-hour long inspections
- Always maintaining a professional appearance and attitude
- Discernment of confidentiality
To be considered for this position, candidates will be required to submit a video interview and consent to a background screening. Offers will be extended upon video review for the right candidates so make sure to prepare and present yourself as if you were interviewing in-person. This client is immediately looking to get candidates started!
Director - Manufacturing Site Inspection Management, Quality (Boston)
Posted 12 days ago
Job Viewed
Job Description
Job Description
General/Position Summary
The Director, CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the inspection management related to CMC activities of the internal manufacturing site for Cell & Gene. This role will be responsible for the development of an inspection program for site compliance and maturity, inspection preparation, consistent state of readiness and inspection management. The role is responsible for designing the program, identifying risks, driving mitigation of such risks and supporting cross-functional partners in ensuring execution.
Additional responsibilities include support for external site inspection readiness. Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone with significant experience in establishing manufacturing site inspection programs from development to commercial and successfully executing to maintain a constant inspection readiness site.
This is a Cell & Gene manufacturing site based role located in the Boston Seaport.
Key Duties & Responsibilities
- Serves as manufacturing site CMC Inspection Lead with responsibility for the overall strategic direction, oversight, performance and effectiveness of the site inspection program.
- Responsible for identification of compliance gaps/risks, drives alignment on mitigation and assures action execution to closure.
- Develops and implements strategies for inspection readiness, including mock inspections, training, and site preparation visits.
- Partners with the site QA leadership and cross-functional leadership for coordination and alignment in ensuring overall execution, readiness and site maturity adequacy.
- Collaborating with cross-functional teams to develop and implement effective corrective and preventive actions (CAPAs) in response to audit and inspection findings.
- Collaborates with the Global Quality Audit and Inspection Management to enable execution and maturity of site for pre-approval inspection and other inspection readiness.
- Monitoring and analyzing key performance indicators (KPIs) related to internal audits, inspections and compliance, and identifying areas for improvement.
- Communicates status, risks, and escalations with management through governance forums and ongoing report outs.
- Leads/Engages/Support in Quality projects ensure successful planning, execution and on-time delivery.
- Ensure activities and deliverables are in compliance with Global HA regulations, Vertex SOPs and industry best practices.
- Provides functional area leadership and management through the execution of Goals, Employee learning and development, and budget forecasting.
Required Education Level
Bachelor's degree in a Scientific/Engineering/Lifesciences field.
Required Experience
Typically requires 12+ years of relevant industry experience in a commercial manufacturing site in biotechnology/regulated pharmaceutical environment.
Required Knowledge/Skills
- In-depth GxP experience with current knowledge of industry trends, HA regulations & expectations, and best practices
- Extensive knowledge of commercial readiness, with inspection planning/coordination and management for regulatory authority inspections at a manufacturing site
- Broad knowledge of Cell & Gene therapy and/or Biologics, aseptic manufacturing processing.
- Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
- Strong leadership skills with the ability to organize and execute tasks effectively.
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
- Ability to apply risk management principles to decision making and operational priorities.
- Ability to manage multiple projects, work in a dynamic environment and communicate effectively with senior leaders.
Other Requirements
5% travel may be required.
#LI-onsite
Pay Range:
$176,000 - $264,000Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
On-Site DesignatedFlex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at
#J-18808-LjbffrPart Time Site Inspection Representative - Texarkana, TX/AR
Posted 23 days ago
Job Viewed
Job Description
The CSI Companies is actively searching for outgoing candidates with in-person customer service experience to fill several Site Inspection Representative roles with a high-profile company in Texarkana, TX/AR. This is a long-term contract opportunity expected to be a year or more. Schedule: The hours per week are based upon the number of surveys in a Contractor's area but will be during normal business hours, Mon-Fri 8am-5pm. May be part time and should not exceed 40 hours. Contractor to be utilized on an as needed basis based on the client's issuance of locations to be visited. About the job: This is a COVID-conscious role with limited interaction that requires commuting to different healthcare facilities to conduct fieldwork (surveys, site visits, verifications, etc) by using a company-provided application on one's personal smartphone. Site visits will be either observational or detailed in nature. Observational site visits will entail minimal contact with staff or customers, photos will be taken and a report will be filed. Detailed site visits will be more time consuming and will require contact with staff to conduct a basic interview, take photos and file a report. The goal of site visits is to confirm outlined operation and/or compliance related information. Contractors will be expected to maintain a low profile and strict confidentiality. Candidates within this role will have the opportunity to manage their own schedule, travel in safety and conduct surveys in order to validate the legitimacy of medical sites. This position offers:
- Competitive compensation for hours worked
- The opportunity to master inspection strategies and techniques within a long-term contract
- Schedule flexibility due to autonomous out-of-office workload
- Limited in-person interaction on sites
- Expedited digital new-hire onboarding process
- A positive company culture and room to grow!
- High school degree or GED at minimum
- Completion of a 2-4 hours virtual training course
- Personal transportation to commute to and from sites located within a 50-mile radius
- Ownership of a smartphone with reliable camera quality for relevant survey documentation
- Ability to learn and navigate company application (training provided)
- Willingness to travel to various sites to conduct up to two-hour long inspections
- Always maintaining a professional appearance and attitude
- Discernment of confidentiality
To be considered for this position, candidates will be required to submit a video interview and consent to a background screening. Offers will be extended upon video review for the right candidates so make sure to prepare and present yourself as if you were interviewing in-person. This client is immediately looking to get candidates started!
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