Principal Quality Assurance Reviewer

When & Where
- Location: Rensselaer, New York, United States
- Work model: Monday-Friday, 8am-4:30pm

Discover Your Role
- Independently reviews and approves investigations into non-conformances and proposed actions to prevent reoccurrences
- Reviews laboratory investigations into out of specification (OOS) and out of trend (OOT) results
- Reviews supplier corrective action requests and proposed vendor actions
- Coaches investigation teams; prepares investigation reports with recommendations for medium/high severity non-conformances
- Analyzes and evaluates investigation information; summarizes findings and trends
- Presents quality considerations and recommendations to multi-level management
- Reviews primary data sources to assure investigative conclusions are accurate and compliant with cGMP standards
- Provides quality reviews and oversight for a wide range of investigations
- Monitors production processes and quality systems data to support investigations and track efficiency of changes
- Participates in and/or leads cross-functional study teams
- Captures, trends, and analyzes process-related data to drive consistency and timeliness
- Trains employees on investigative processes and techniques
- Coordinates and/or leads cross-functional meetings with multiple departments

This Role Requires
- BS/BA in Life Sciences, Engineering, or related field; or equivalent education/experience
- Principal QA Specialist: 8+ years relevant experience
- Staff QA Specialist: 10+ years relevant experience
- Level determined based on experience
- Experience with sterile drug product manufacturing, fill finish and/or quality control testing

#REGNQA

Apply now.