Investigation Specialist

Regeneron Pharmaceuticals • Rensselaer, IN

2d • $62,355 - $128,700 • Onsite

About The Position

Regeneron is seeking Investigation Specialists to join its deviation investigation teams. These positions perform compliance-related tasks needed to complete investigations and implement robust corrective actions in support of manufacturing operations. Openings are available in Technical Operations and Quality Control in Rensselaer, New York. The work model is Monday through Friday, 8:00 a.m. to 4:30 p.m. The level—Associate Investigation Specialist, Investigation Specialist, or Senior Investigation Specialist—will be determined based on experience.

Requirements

• A bachelor's degree in life sciences, engineering, or a related field; proven experience may be substituted for the education requirement.
• Related experience by level: Associate Investigation Specialist, 0–2+ years; Investigation Specialist, 2+ years; Senior Investigation Specialist, 5+ years. Level will be determined based on experience.

Responsibilities

• Independently investigate non-conformances and prevent recurrence in support of manufacturing operations.
• Prepare investigation reports, including recommendations on findings for medium- and high-severity non-conformances.
• Analyze and evaluate information collected through investigations, and summarize information and trends in investigation reports.
• Review completed batch records and logbooks in accordance with cGMP standards to support investigations.
• Review, edit, and revise controlled documents, including batch records, logbooks, and SOPs, in accordance with cGMP standards and written procedures.
• Monitor production processes to collect data supporting investigations and track the efficiency of changes.
• Participate in and/or lead cross-functional study teams to achieve results and support or author investigations.
• Gather, trend, and analyze process-related data to drive consistency and timeliness.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits. Availability depends on country and role.

What This Job Offers

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