Senior Quality Assurance Specialist
Company: Stratacuity
Location: Cambridge
Posted on: March 17, 2023
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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
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