26 May
Massachusetts,
Boston
, 02108
Boston
USA
Vacancy expired!
Job#: 1338503 Job Description: Sr. QA Specialist, External Programs 1338503Location: Boston, MA (Hybrid)Science: Small MoleculeTherapeutic Area: Rare DiseasesJob Overview: The Sr. QA Specialist will provide support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs.Responsibilities:- Reviews master batch records and provides customer approval for quality tasks for externally manufactured products
- Performs final review of executed batch and/or critical systems documentation and determines acceptability by using standard operating procedures
- Ensures presence and acceptability of all required documentation prior to the release of the product and/or system.
- Reviews and approves investigations, CAPA's and change controls for external programs
- Supports the day-to-day management of the batch release process.
- Supports annual product quality reviews
Qualifications:- Master's degree with 3-5 years of relevant work experience, or Bachelor's degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.
- Demonstrated success by independently leading cross-functional teams
- Experience providing QA support and oversight of GMP manufacturing operation
- Experience successfully leading event investigations, Root Cause Analysis and CAPA
- Experience with network-based applications such as Oracle, TrackWise, Veeva
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.EEO EmployerApex 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 . Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.
Vacancy expired!
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