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