Kelly® Science & Clinical is seeking a Quality Control Scientist with one of our clients, a biotechnology company in Seattle, WA. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Workplace: Onsite in Seattle, WA
Salary: $90,000-120,000 + equity
This Quality Control (QC) Biochemical Assay Scientist will be involved in the design and execution of various types of bioassays, supporting assay method development, validation, and assay transfer from R&D to the Quality Control team. This individual will devise, troubleshoot, and validate bioassays for in-process control and lot release. They will also be responsible for maintaining and reviewing cGXP records, assisting in managing quality events, data trending, and overall supervision of QC bioassay analysis activities. This position will work closely with scientists on the Assay Development research team, as well as the Quality Control team.
Responsibilities
This position requires working under the 21 CFR part 210 /211 standard pharmaceutical cGXP quality system processes.
- In charge of new assay transfer from R&D to QC, to ensure robust assays can be executed in QC with a set of GMP compliance documentation. Analytical assay platforms such as PCR, qPCR, ELISA, MSD, and enzyme activity assays are the focus.
- Conduct a review of laboratory data and data trending.
- Troubleshoot assays and assist other lab members in ensuring high-quality experimental execution and data recording
- Handle and track BSL-2 material
- Author and review quality documents such as SOP, OOS/OOT, CAPA, and Change Control.
- Author test methods, development reports, study protocols, and reports.
- Maintain and operate laboratory equipment safely and efficiently, including coordinating and conducting preventative maintenance, cleaning, calibration, and qualification activities
- Monitor, review, and trending of stability data.
- Coordinate sample analysis with on-site staff and third-party labs for stability, routine, qualification, verification, and validation activities
- Create, review, and edit analytical methods and procedures to contribute to continuous improvements in safety, quality, and efficiency.
Qualifications
- PhD in biochemistry, enzymology, or a closely related scientific field plus 3 years of work experience in Quality Control/Development in a GMP compliance environment or a bachelor’s or master’s degree in biochemistry or a related scientific field plus 5 years of work experience in Quality Control
- Experience developing highly reproducible custom immunoassays, PCR, ddPCR assays, enzyme assays, cell-based assays, and/or other types of essays
- Thorough understanding of the theory and practice of dPCR, cell-based binding potency, ELISA, and enzyme activity assays
- Experience setting up, optimizing, and deploying bioassay is highly desired.
- Experience in applying statistical techniques in data analysis and data trending.
- Demonstrated technical aptitude and experience with pharmaceutical tech transfer including analytical methods verification, and validation that are suitable for different phases of FDA clinical trial phase requirements.
- Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask.
- Thorough knowledge of relevant cGxP, ISO 9001, and ICH requirements for document control and quality records
- Experience with electronic biological sample organization and tracking is preferred
What happens next:
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.