Marin Metro Area, CA
The QC In-Process (QCIP) Analyst is responsible for performing microbiological and analytical test methods on in-process intermediates and varying stages of drug products, under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the following analyses and concepts: Protein determination by BCA, Bradford, and UV Absorbance, Enzyme activity, Endotoxin detection, Bioburden quantification, HPLC, and Total Organic Carbon.
Functional activities may include: performing a wide variety of microbiological and/or analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorm further development or improvement ideas for procedures.
Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognize deviations from routine practices. Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting and incorporating feedback. Must also demonstrate the ability to both manage time and prioritize routine work effectively.
- Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
- Execute microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
- Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges.
- Perform and collaborate with co-workers to ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.
- Assist with monitoring and the control of laboratory supply and critical reagent inventories.
- Bachelor of Science degree.