QA Investigation Specialist

Regeneron Pharmaceuticals • Rensselaer, IN

23h • Onsite

About The Position

We are currently looking to fill a QA Investigation Specialist position with our Bulk Drug Substance Manufacturing Quality Assurance team. This position performs all compliance related tasks vital to complete investigations and implementation of robust corrective actions for supporting manufacturing operations.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related field
• Associate Specialist – 0-2 years relevant experience
• Specialist – 2+ years relevant experience
• Senior Specialist – 5+ years relevant experience
• May substitute proven experience for education requirement.
• Excel in a quality driven organization
• Have an understanding of biologics manufacturing operations
• Are organized and have an attention to detail
• Can prioritize multiple assignments and changing priorities
• Are able to learn and utilize computerized systems for daily performance of tasks
• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Responsibilities

• Independently investigating non conformances and preventing reoccurrences in support of manufacturing operations
• Preparing investigation reports that include recommendations on investigation findings for medium/high severity non conformances
• Analyzing and evaluating information captured through investigations, summarizes information and trends in investigation reports
• Communicating findings and recommendations at group meetings
• Reviewing completed batch records and logbooks in accordance with cGMP standards in support of investigations
• Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
• Monitoring production processes to acquire vital data in support of investigations and track efficiency of changes
• Participating in and/or leading cross-functional study teams to get results, support and or author investigations
• Gathering, trending, and analyzing process related data to drive consistency and timeliness
• Documenting all training
• Training new employees on investigative processes and techniques
• Coordinating and/or leading cross-functional meetings with multiple departments

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees