Manager/Sr. Manager, Quality Control/Quality Assurance 1098926
Job Scope & Purpose:
Our Cambridge based client is seeking an experienced QC/QA Manager to join their growing team. The incumbent will be responsible for reviewing all QC/QA related documents in support of process validation campaigns, finished drug products, drug substances, and stability samples, including specifications, method validation, and stability protocols and reports. If you have previous experience ensuring all QC/QA activities are in accordance with regulatory and industry guidelines, continue reading and consider applying today.
Primary Job Requirements:
- BS/MS in a science or technical field with a minimum of 7 years' working in a Quality Control pharmaceutical industry-relevant cGMP experience
- Strong technical knowledge of analytical chemistry including advanced knowledge of method transfer/validation, chromatography, and all pharmaceutical development analytical laboratory techniques
- Effective written and oral communication skills at individual, team, and organizational levels
- Experience working on cross-functional teams and managing relationships in a collaborative, constructive manner with internal departments and international vendors and partners
- Extensive knowledge of cGMP, 21 CFR 211 and 21 CFR Part 11, specifically, ICH Q7, Q1 (A, B, C, D, E, and F) Q2, Q3 (A, Band C) and USP, EP and JP test requirements
- Detailed knowledge of Quality management systems
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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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.
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 .