About this opportunity
Regeneron lists this Principal Quality Assurance Reviewer opportunity in town of east greenbush, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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.
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 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
This Role Requires
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
Level will be determined based on experience
Experience with sterile drug product manufacturing, fill finish and/or quality control testing
#REGNQA
Does this sound like you? Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$92,200.00 - $176,000.00
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.