Senior QA Specialist - Onsite 3rd Shift

Regeneron Pharmaceuticals, Inc.

City of Rensselaer (NY)

On-site

USD 79,000 - 129,000

Full time

6 days ago

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Job summary

Regeneron Pharmaceuticals, Inc. seeks a Senior Quality Assurance Specialist to lead on-floor activities supporting dispositioning of product and/or raw materials, ensuring cGMP and QA policy compliance.

The role includes deviation/CC/CAPA handling, investigations, and document reviews with external partners. The successful candidate will train and mentor staff, provide QA guidance on the floor, review critical records, and participate in continuous process improvements while supervising direct

Qualifications

BS/BA in Life Sciences, Engineering or related field required.
Experience with sterile drug product manufacturing, fill finish and/or quality control testing.
6+ years for Principal QA Specialist; 8+ years for Staff QA Specialist.

Responsibilities

Represent QA on-floor for deviations, change controls, CAPAs and investigations.
Communicate QA policy to external partners and provide regulatory input.
Train and mentor employees on QA processes and expectations.
Provide QA guidance to events and questions arising on the floor.
Disposition of product, including MR review and document/source data reviews.
Review, edit, or approve Regeneron controlled documents and investigations.
Contribute to continuous improvement of processes and procedures.
Supervise direct reports and conduct monthly performance feedback.