GMP QA Manager

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Apex Systems
QA, Manager, Quality, System, Management, Biology, Systems, Scripts
Full Time

Job Description

GMP QA Manager, 1095267

Job Scope & Purpose:

We are seeking a GMP QA Manager whose responsibilities will include QA support of clinical phase manufacturing and regulatory activities, management of batch manufacturing and testing activities at CMOs and CTLs to ensure cGMP compliance, and administration of document control in our clients company systems.

Primary Job Responsibilities:
  • Act as subject matter expert (SME) for GMP QA topics
  • Execution of Company lot disposition packages for drug substance, drug products, and finished clinical trial material
  • Assist in Quality System development; Write, revise, and periodically review SOPs
  • Management of: Document Control, Training, Deviations and CAPAs, Vendor Management
  • Participate in CMC team meetings and others, providing QA support
  • Review of master batch records, specifications, test methods, stability protocols, and reports
  • Review and approve executed batch records, analytical data, change controls, deviations, OOS, etc.
  • Review of CMO lot disposition packages
  • Attend CMO/Company joint team meetings, follow through open quality events

Primary Job Responsibilities:
  • BS/BA in Chemistry, Biology or a related life science; 5-10 years of experience within GMP quality functions of pharmaceutical/biotech industry
  • Be independent and proactive
  • Strong execution of day-to-day activities
  • Have experience working in a small-team, dynamic environment
  • Experience in auditing CMOs and CTLs is a plus

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.



Code:RegQA

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or


Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

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Dice Id : apexsan
Position Id : BHJOB2374_1095267
Originally Posted : 2 months ago

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