QA Lab Support Specialist: Biologics & Compliance

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 110,000; Full time

Benefits offered by this job

Student loan paydown program & tuition

Family care benefits

Relocation assistance

Inclusion & well-being programs

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Quality Assurance Specialist to support lab operations at our Rensselaer, NY facility. The role focuses on QA policy adherence, data review, and CAPA/change control activities to ensure cGMP compliance.

You will partner with QC labs, facilities, and external teams to maintain a strong quality profile. The ideal candidate has a life sciences background with 4+ years of QA experience, and the ability to train and guide junior staff while driving

Qualifications

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

Responsibilities

• 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

Skills

QA policy & procedures

Lab support

Deviations & CAPAs

Documentation review

Regulatory compliance

Mentoring junior staff

Education

Bachelor's degree in life sciences

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Quality Assurance Specialist to support lab operations at our Rensselaer, NY facility. The role focuses on QA policy adherence, data review, and CAPA/change control activities to ensure cGMP compliance.

You will partner with QC labs, facilities, and external teams to maintain a strong quality profile. The ideal candidate has a life sciences background with 4+ years of QA experience, and the ability to train and guide junior staff while driving