QA Investigation Specialist
Regeneron
Full-time
Remote friendly (Rensselaer, NY)
United States
Operations
Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
QA Investigation Specialist, part of Bulk Drug Substance Manufacturing Quality Assurance. Performs compliance tasks vital to complete investigations and implementing robust corrective actions to support manufacturing operations.
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
Qualifications
- Required: Bachelor’s degree in Life Sciences, Engineering, or related field
- Experience levels and corresponding requirements:
- Associate Specialist – 0-2 years
- Specialist – 2+ years
- Senior Specialist – 5+ years
Skills
- Excel in a quality driven organization
- Understanding of biologics manufacturing operations
- Organized with attention to detail
- Ability to prioritize multiple assignments and changing priorities
- Ability to learn and utilize computerized systems for daily performance of tasks
Education
- Bachelor’s degree in Life Sciences, Engineering, or related field