Sr. Associate, Quality Assurance

Job#: 1376336

Job Description:

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.
Responsibilities:

• 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.

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.
[email protected]

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 [email protected] or 844-463-6178.