QA Specialist (On the Floor)

Regeneron Pharmaceuticals, Inc; New York (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Assurance Specialist to ensure compliance with QA policies and drive continuous process improvements. The role involves training staff, managing quality assurance activities, and supporting product disposition in a biologics manufacturing environment.

Qualifications

• Experience levels vary: 2+ years for Associate, 4+ years for QA Specialist, 6+ years for Sr QA Specialist.

Responsibilities

• Lead QA activities for product and raw material disposition.
• Train and mentor employees on QA processes.
• Drive continuous process improvements.

Skills

Attention to Detail

Organization

Quality Assurance

Biologics Manufacturing

Education

Bachelor’s Degree

Job description

We are currently looking to fill a Quality Assurance Specialist position. This role involves leading activities on the floor to support product and raw material disposition, ensuring compliance with QA policies, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

Available Work Schedule:

• Wednesday-Saturday, 2nd shift: 2pm-12:30am

Typical responsibilities include:

• Representing QA during Deviations, Change Controls, CAPAs, including investigation and resolution
• Communicating QA policies to external partners and providing regulatory input
• Training and mentoring employees on processes and procedures
• Providing QA guidance on the floor in real-time
• Disposing of products through record and document reviews
• Reviewing and approving controlled documents and investigations
• Driving continuous process improvements

Ideal candidates:

• Thrive in a quality-driven environment
• Understand biologics manufacturing
• Are organized with keen attention to detail
• Can prioritize multiple tasks
• Can stand for extended periods during floor activities

Qualifications:

• Bachelor’s degree required
• Experience levels vary by role:
• Associate QA Specialist - 2+ years
• QA Specialist - 4+ years
• Sr QA Specialist - 6+ years

Experience may substitute for education; level is determined by relevant qualifications.