Quality Control Data Reviewer
Regeneron
Full-time
On-site
Rensselaer, NY
Operations
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Role Summary
Quality Control Data Reviewer
We are looking for a QC Data Reviewer (Associate Level – Senior Level) who can ultimately perform data reviews to support release, stability programs, and lab operation within Quality Control. This role continuously strives to follow all pertinent regulatory agency guidelines to drive performance. This position is a Monday - Friday 8am-4:30pm schedule.
Responsibilities
- Executing detailed data review for analytical test results generated by QC for compliance with cGMP, internal SOPs and Specifications
- Supporting production, stability studies, and lab operations
- Reviewing release and stability data, trend charts of reference standards, lab equipment calibration records and logbooks
- Performing detailed data review for analytical test results created by contract testing labs to assure correctness and accuracy
- Maintaining and updating relevant SOPs for data review and reporting
- Collaborating with Stability and other groups to support stability report writing and regulatory updates
- Participating in all vital training activities
Qualifications
- Required: BS/BA in Chemistry, Biology, or related field
- Required: Willingness and ability to work Monday - Friday 8am-4:30pm
- We may substitute other proven experience in lieu of a degree
- Level will be determined by demonstrated experience
- Solid understanding of data reviewing and regulatory agency guidelines
Skills
- Results-oriented with ability to analyze data trends
- Ability to work efficiently as an individual as well as with others
- Strong communication skills and ability to build beneficial relationships with peer groups