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
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.
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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