Contract Principal Specialist, QA Validation 2051578Location: Cambridge, MA (Onsite)Science:BiologicsJob Overview:As a Quality Assurance Validation Specialist, youll 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. 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. EEO EmployerApex 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-###-#### .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.