Senior QA Investigation Specialist: cGMP & Cross-Functional

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 79,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Sr. QA Investigation Specialist to support Batch Review Operations.

You will be the first point of contact for receiving and processing complaint notifications from external sources, ensuring investigations align with cGMP standards and manufacturing needs. Responsibilities include leading investigations, evaluating data, and presenting quality considerations to management.

Qualifications

• BS/BA in Life Sciences or Engineering or related field (or equivalent).
• Equivalent combination of education and experience may be acceptable.
• Advanced degree is a plus.

Responsibilities

• Review investigations into non-conformances and propose actions to prevent recurrence.
• Lead laboratory investigations into OOS and OOT results.
• Handle supplier corrective action requests and vendor actions.

Skills

Investigations

cGMP knowledge

Documentation

Education

BS/BA in Life Sciences or Engineering

Equivalent education/experience

Advanced degree (preferred)

Tools

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Job description

Regeneron Pharmaceuticals is seeking a Sr. QA Investigation Specialist to support Batch Review Operations.

You will be the first point of contact for receiving and processing complaint notifications from external sources, ensuring investigations align with cGMP standards and manufacturing needs. Responsibilities include leading investigations, evaluating data, and presenting quality considerations to management.