QA Specialist (On the Floor)

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

Job summary

A leading company in the biopharmaceutical industry is seeking a QA Specialist to ensure compliance with quality assurance policies and support product dispositioning. The role involves leading quality assurance activities on the manufacturing floor, training employees, and improving processes. Ideal candidates will have a Bachelor's degree and relevant experience in a quality-driven environment.

Qualifications

• 2+ years for Associate QA Specialist, 4+ years for QA Specialist, 6+ years for Senior QA Specialist.

Responsibilities

• Handle Deviations, Change Controls, CAPAs, including investigations.
• Train and mentor employees on processes and procedures.
• Provide on-floor QA guidance during operations.

Skills

Attention to Detail

Organizational Skills

Problem Resolution

Education

Bachelor's Degree

Job description

Join to apply for the QA Specialist (On the Floor) role at Regeneron.

We are currently looking to fill a Quality Assurance Specialist position. This role involves performing and leading activities "on the floor" to support product and raw material dispositioning while 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:

• Represent QA in handling Deviations, Change Controls, CAPAs, including investigations and problem resolution.
• Communicate QA policies to external partners and provide regulatory input.
• Train and mentor employees on processes and procedures.
• Provide on-floor QA guidance during operations.
• Disposit products through record and document review.
• Review, edit, or approve controlled documents and investigations.
• Continuously evaluate processes for improvement.

This role may be suitable if you:

• Excel in a quality-driven environment.
• Understand biologics manufacturing operations.
• Are organized with keen attention to detail.
• Can prioritize multiple tasks and adapt to changing priorities.
• Can stand for extended periods on the floor.

Qualifications:

Must hold a Bachelor’s degree and relevant experience:

• Associate QA Specialist: 2+ years
• QA Specialist: 4+ years
• Senior QA Specialist: 6+ years

Experience may substitute for education. Level is determined by relevant qualifications.