Data Reviewer (QC)
Our clients trust us to deliver excellence in data and bioanalysis and in this San Diego onsite role and you will be a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure data integrity standards are met across various equipment, regulatory settings, and workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based assays, cell work, gene therapy and more.
We are looking for candidates who have practical regulatory experience with bioanalytical data in a corporate GxP setting. This role is not lab-based, but our best candidates have lab experience or experience with the types of assays we do here. You are self-motivated, an independent thinker, and highly organized. If you influence others by being a trusted advisor and advocate, are energized by a deadline-driven environment, and aspire to provide the best caliber of data to our customers, then you’ll be right at home here at BioAgilytix.
- 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).
- Identify deviations, OOS and OOT associated with Bioanalytical Operations data as applicable
- 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
- Assist in educating, guiding and influencing the scientific staff in regard to best practices in GxP compliance
Minimum Acceptable Qualifications
- 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
- Ability to perform your role independently with attention to detail and minimal oversight
- Ability to perform technical review of data following GxP regulations and scientific principles
- Expertise in communicating and building relationships with others, where all feel heard and respected
- The confidence to make and share observations in a considerate manner
- Proficiency in LIMS and Quality Management software packages
- 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
- Two-Four (2-4) years’ experience performing data review in a GxP environment
- Experience with relevant bioanalytical methods such as immunoassays, cell-based assays, or qPCR
- Entgelttyp Gehalt
- BioAgilytix San Diego, 9050 Camino Santa Fe, San Diego, Kalifornien, Vereinigte Staaten von Amerika