Investigation Specialist

About the role

Join our teams in internal fill finish & global manufacturing at Regeneron, a science-driven organization dedicated to developing life-changing medicines for people with serious diseases. This position involves independently investigating non-conformances and implementing corrective actions to support manufacturing operations.

Responsibilities

• Independently investigate non-conformances and prevent their recurrence in support of manufacturing operations
• Prepare investigation reports detailing findings and recommendations for medium/high severity non-conformances
• Analyze and evaluate information from investigations, summarize findings, and identify trends in investigation reports
• Review and edit batch records and logbooks to ensure compliance with cGMP standards
• Monitor production processes to gather data for investigations and track efficiency of changes
• Participate in and lead cross-functional study teams to complete investigations
• Gather, trend, and analyze process-related data to enhance consistency and timeliness

Requirements

• Bachelor's degree in life sciences, engineering, or a related field; equivalent experience may substitute for education requirement
• Associate Investigation Specialist: 0-2 years of experience
• Investigation Specialist: 2+ years of experience
• Senior Investigation Specialist: 5+ years of experience

Qualifications

• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Proficiency in Microsoft Office Suite
• Ability to work independently and as part of a team

Skills

• Knowledge of cGMP regulations
• Experience with batch records and logbook reviews
• Strong attention to detail and organizational skills
• Ability to manage multiple projects simultaneously

Benefits

Regeneron offers a competitive and comprehensive total rewards package including:

• Annual bonuses or other incentive plans
• Equity awards
• Pension or retirement benefits
• 401(k) company match
• Health and wellness programs
• Fitness centers
• Insurance benefits (medical, dental, vision, life, and disability)
• Paid time off
• Family support benefits

For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$62,355.00 - $110,000.00 annually

Schedule

Monday-Friday, 8am-4:30pm