Quality Assurance Specialist, Lab Support

About the role

We're seeking a Quality Assurance (QA) Specialist to focus on lab support for our fill finish facility and quality control laboratory areas. They will ensure compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

What You'll Do

• Communicates QA policy and procedures; liaises with Quality Control laboratories, support laboratories, facilities, internal or external partners and stakeholders to ensure a successful compliance profile
• Represents Quality Assurance in support of complex Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Actively participates in QC laboratory oversight activities such as data review and laboratory walkthroughs
• Performs activities associated with review, edit, and approval of QC generated documentation. Activities may be on the floor or at a desk
• Collaborates with key partners in the business to proactively identify areas for improvement and develop solution strategies
• Trains and/or mentors junior employees, including providing insights and education on processes and procedures
• Provides consultation or advice in alignment with QA policies
• Adheres to Regeneron processes and procedures and may lead Continuous Improvement initiatives
• Demonstrate good understanding of analytical laboratory and biologics manufacturing operations is preferred

Qualifications

Requires B.S in life sciences or related field; may substitute proven experience for education requirement.

• Associate Quality Assurance Specialist: 2+ years of experience
• Quality Assurance Specialist: 4+ years of experience
• Senior Quality Assurance Specialist: 6+ years of experience
• Level will be determined based on experience

Location & Schedule

Rensselaer, New York, United States. Monday-Friday, 8am-4:30pm.

Benefits

• Student loan paydown program & tuition reimbursement
• Family care benefits
• Relocation assistance
• Inclusion, culture and well-being programs (including physical & mental health)

Pay

$62,355.00 - $110,000.00 annually.