Sr. Associate, Quality Assurance
Sr. Associate, Quality Assurance 1376336
Location: Cambridge, MA (Hybrid)
Science: T-Cell Therapies
Therapeutic Area: Oncology
Job Overview: This position supports quality operations, documentation control, and Research Operating Procedure development, including product review, training tracking, change management, deviation tracking, equipment validation, and non-GMP department training.
- Maintain and update quality supporting documentation for GMP production, including tech transfers and equipment qualification/validation at contract manufacturing organizations (CMOs).
- Review manufacturing records and conduct batch release for clinical lots to ensure compliance with quality standards.
- Manage Quality Change Control projects, including reviewing Change Control records and providing QA support for changes related to T cell therapy product, while also investigating and providing support for deviations in the manufacturing, testing, and shipping of raw materials or drug product.
- Bachelor’s degree in biological sciences or related field, with minimum 5 years experience in GMP operations in biotech or biologics, or equivalent education/work experience, and prior experience in quality function in commercial environment are required.
- Knowledge of Quality Management System elements and ability to maintain and improve systems supporting QMS, as well as familiarity with working in a manufacturing or QC environment applying GMPs in conformance with FDA, MHRA, EU and ICH standards, are required qualifications.
- Good interpersonal, verbal and written communication skills, ability to work in a fast-paced small company environment with minimal direction, and preferred external auditing experience, are also required.
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 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.