Location : Cambridge, MA (Onsite)
Science : Biologics
Job Overview : As a Quality Assurance Validation Specialist, you'll guarantee system compliance and integrity, expertly handling validation and quality events with tools like Veeva QMS, Blue Mountain RAM, and Kneat.
Primary Job Responsibilities :
- Lead benchtop equipment validation, ensuring compliance and resolving discrepancies.
- Manage computer systems validation, including Veeva and LIMS, with a focus on data integrity.
- Oversee validation documentation and support quality events using Veeva QMS.
- Apply risk-based strategies and collaborate with key departments to meet quality standards.
Primary Job Requirements :
- Bachelor’s degree and over 8 years in biopharma QA Validation, experienced in validation deliverables.
- Expert in benchtop equipment and Computer Systems Validation (CSV) with GAMP 5 knowledge.
- Proficient in data integrity and regulatory compliance (FDA, EMA, ICH) for QA operations.
- Skilled in paperless validation systems (Veeva, Blue Mountain RAM) and risk-based strategies.
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.
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