QA Investigation Specialist

Regeneron Pharmaceuticals•Rensselaer, IN

1d•$66,400 - $108,400•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.
Ability 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

Nice To Haves

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

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