Senior Quality Assurance Specialist

Company: Stratacuity
Location: Cambridge
Posted on: March 17, 2023

Job Description:

Senior Quality Assurance Specialist 1315731

Location: Cambridge MA (Hybrid)

Science: CAR-T

Therapeutic Area: Oncology

Job Overview: The Sr. QA Specialist will ensure deviations, change controls, and CAPAs are reviewed, approved, and closed in a timely manner. The incumbent will support start-up activities for a new manufacturing facility and provide ongoing support for GMP activities both internally and at CDMO.

Responsibilities:

* Support management and facilitation of site review boards for CAPA, change control, and deviation
* Lead and/or support thorough investigations of internal and external deviations
* Review and approve all internal and external deviations, CAPA and Change Controls
* Provide quality oversight of CDMO QMS-related deviations, change control, and CAPA

Qualifications:

* BS in Life Sciences with a minimum of 6 years of experience in a CGMP environment, with a strong knowledge of FDA and EU regulations
* Experience setting up GMP operations and systems in a new facility is beneficial
* Proficient in writing and approving Quality Systems, including but not limited to deviations, change controls, and CAPA
* Skilled in the use of root cause analysis tools
* Excellent organizational skills

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.

achan@stratacuity.com

Code:RegQA

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.

Keywords: Stratacuity, Cambridge , Senior Quality Assurance Specialist, Other , Cambridge, Massachusetts