Quality Assurance Specialist (On the floor)

Regeneron Pharmaceuticals•Rensselaer, NY

1d•$62,355 - $128,700•Onsite

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Quality Assurance (QA) Specialist to join our QA Drug Product team. This position will support visual Inspection, assembly, and packaging operations performed at Regeneron’s internal Fill/Finish facility. They will provide floor support during production activities and contribute to establishing/updating procedures and policies to ensure assigned areas are operating to current FDA and International regulatory body requirements. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

Requires B.S in life sciences or related field; may substitute proven experience for education requirement
Assoc QA Specialist : 2+ years of experience
QA Specialist : 4 + years of experience
Sr. QA Specialist: 6+ years of experience
Level will be determined based on experience
Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
Qualified applicants must be able to pass the following vision tests; Ishihara (colorblindness) and Jaeger (paragraphs of decreasing size) as part of the requirements of this role

Responsibilities

Oversee programs that support visual inspection, assembly, and packaging operations at the drug product facility
Ensure facilities, equipment, materials, processes, and procedures comply with good manufacturing practices, good documentation practices, safety, and Regeneron requirements
Develop, update, review, and approve standard operating procedures, specifications, and other documents supporting drug product operations
Provide quality oversight and guidance during on-the-floor manufacturing activities
Execute daily on-the-floor oversight to verify facilities, equipment, materials, and documentation comply with standard operating procedures and safety standards
Perform material quarantine and segregation and execute line clearance activities
Perform acceptable quality level sampling plan
Review and approve procedures, documents, and records, including batch production records and protocols
Ensure electronic and paper batch records are complete, accurate, and compliant with written procedures
Provide quality support for electronic batch record design, review, and approval
Author, review, and approve quality documents, including standard operating procedures, risk assessments, training materials and records, protocols, and reports
Support and represent quality assurance during audits and inspections, including direct interactions with regulatory agencies as needed