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Data Reviewer (Qc Specialist)
Company | BioAgilytix |
Address | Durham, NC, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-06-12 |
Posted at | 1 year ago |
At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.
- Assist in educating, guiding and influencing the scientific staff in regard to best practices in GxP compliance
- Perform Quality Control (QC) technical, scientific, and compliance review of data and documentation generated by the Bioanalytical Operations group in support of regulated studies (e.g. GLP, GMP)
- Issue QC review observations and work closely with the scientific staff to ensure data integrity
- Collect metrics data used to monitor the QC reviews, and may identify process improvements
- Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable
- Two-Four (2-4) years’ experience performing data review in a GxP environment
- Bachelor’s degree in biological science or related field, with between 2-10 years’ experience working in biotech, pharmaceutical, CRO/CMO or similar organization; or Master’s or PhD. with equivalent experience
- Knowledge and/or extensive knowledge of GxP regulations
- Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR
- Ability to perform technical review of data following GxP regulations and scientific principles
- Ability to perform your role independently with attention to detail and minimal oversight
- Expertise in communicating and building relationships with others, where all feel heard and respected
- Self-motivated and demonstrated ability to learn and work in a fast-paced environment where multiple concurrent projects must be completed in a timely manner
- Proficiency in LIMS and Quality Management software packages
- The confidence to make and share observations in a considerate manner
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