Sr QA Investigation Specialist

Regeneron Pharmaceuticals • Rensselaer, IN

2d • $78,700 - $128,700

About The Position

The Sr. QA Investigation Specialist supports Batch Review Operations and serves as the first point of contact for receiving and processing complaint notifications from external sources. The role provides quality review and oversight for a broad range of investigations, including manufacturing non-conformances, laboratory results, and supplier corrective actions. It evaluates investigation information, verifies primary data sources against cGMP standards, summarizes findings and trends, and presents quality recommendations to management. The specialist also trains employees on investigation processes and techniques and coordinates or leads cross-functional meetings.

Requirements

• BS/BA in Life Sciences, Engineering, or a related field, or an equivalent combination of education and experience.
• For the Senior Specialist level, 5 years of relevant experience or an equivalent combination of education and experience.

Responsibilities

• Independently review and approve investigations into non-conformances and proposed actions to prevent recurrence in support of manufacturing operations.
• Independently review and approve laboratory investigations into out-of-specification (OOS) and out-of-trend (OOT) results.
• Independently review and approve supplier corrective action requests and proposed vendor actions.
• Analyze and evaluate information captured through investigations and summarize information and trends in investigation reports.
• Present quality considerations and recommendations at group meetings with multiple levels of management.
• Review primary data sources to ensure the accuracy of investigative conclusions in accordance with cGMP standards.
• Provide quality reviews and oversight for a wide range of investigations across differing subject matters.
• Train employees in investigative processes and techniques.
• Coordinate and/or lead cross-functional meetings with multiple departments.
• Receive and process complaint notifications from external sources as the first point of contact.

Benefits

• Annual bonuses or other incentive plans may be offered, depending on country and role.
• Equity awards may be offered, depending on country and role.
• Pension or retirement benefits may be offered, depending on country and role.
• 401(k) company match may be offered, depending on country and role.
• Health and wellness programs may be offered, depending on country and role.
• Fitness centers may be available, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability coverage, may be offered, depending on country and role.
• Paid time off may be offered, depending on country and role.
• Family support benefits may be offered, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior