QA Operations Sr. Specialist
Quality Assurance Operations Specialist 1331768
Location: Cambridge MA (Hybrid)
Science: ADC
Therapeutics Areas: Oncology
Job Overview: The QA Operations Specialist will collaborate with others, build processes, and monitor quality systems. If you’re looking to develop your quality manufacturing skills, continue reading and consider applying today.
Responsibilities:
- Maintain Batch Review and Release Tracking Spreadsheets.
- Review Executed Batch Records with a Phase I through Phase III drug substance and drug product focus.
- Support BLA readiness through documentation reconciliation and load into Veeva Quality Management System
- Ensure external Change Controls have been entered into the QMS assigned to correct SMEs.
Qualifications:
- Minimum 3-5 years of experience working in QA, Quality Systems or QA Compliance
- Have experience with FDA and EU regulations
- Previous experience in Quality Systems Management and/or Quality Operations, with a focus on Batch Record Review, Deviation Tracking, and Change Management
- Understanding of QMS systems, specifically Quality Events (Deviations), CAPA, and Change Control.
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: TechOps
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 employeeservices@apexsystems.com or 844-463-6178.