Principal Quality Assurance Reviewer
About The Position
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Quality Assurance (QA) Specialist/Reviewer to support our Fill Finish facility. In this role, you will perform all compliance related tasks necessary to review and approve investigations and provide quality oversight to the implementation of robust corrective actions for supporting manufacturing operations. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Requirements
- BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
- Principal QA Specialist: 8+ years of relevant experience
- Staff QA Specialist: 10+ years of relevant experience
Nice To Haves
- Experience with sterile drug product manufacturing, fill finish and/or quality control testing is preferred
Responsibilities
- Independently reviews and approves: Investigations into non-conformances and proposed actions to prevent reoccurrences in support of manufacturing operations
- Laboratory investigations into out of specification (OOS) and out of trend ( OOT) results
- Supplier corrective action requests and proposed vendor actions
- Coaches investigation team to enable preparation of investigation reports that include recommendations on investigation findings for medium/high severity non-conformances
- Analyzes and evaluates information captured through investigations, summarizes information and trends in investigation reports
- Presents quality considerations and recommendations at group meetings with multiple levels of management
- Reviews primary data sources to assure the accuracy of investigative conclusions in accordance with cGMP standards in support of investigations
- Provides quality reviews and oversight on a wide range of investigations of differing subject matter
- Monitors production processes and quality systems data to acquire vital data in support of investigations and track efficiency of changes
- Participates in and/or leads cross-functional study teams to get results
- 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
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
