QC Analyst 2
Vista Biologicals provides highly specialized cell culture, process development, and cGMP manufacturing services for the biotechnology and biopharmaceutical industries, utilizing cell culture to support pre-clinical, Phase I - II production.
Vista Biologicals Corporation (VBC) is currently seeking a talented and innovative QC Analyst to join the QC department.
The candidate will be trained in most or all unit operations in their area, often leading the execution of procedures, and performs with minimal supervision.
The QC Analyst is responsible for carrying out analytical method development, and troubleshooting work, executing validation and transfer protocols, writing and reviewing protocols and reports. Also supporting the on-time release, stability, and non-routine testing of pharmaceutical drug substance (DS) and drug product (DP).
- Analytical tests include:
- Reverse-phase HPLC
- SDS Gels
- UV spectrophotometry
- Plate-based assays including ELISAs and cell-based Bioassays, Capillary Electrophoresis, qPCR, SoloVPE, etc.
- Testing of in-process samples, finished product, non-routine samples, packaging, and stability
- Prepare protocols and summaries
- Develop, optimize, validate and troubleshoot analytical test methods
- Draft and revise QC Test Methods/SOPs
- Evaluate results against defined acceptance criteria
- Conduct and document laboratory investigations and deviations to completion
- Knowledge of cGMP principles, safety, proper documentation, and data integrity
- Maintain the laboratory in an inspection-ready state
- Interact with other departments (manufacturing, QA, facilities, etc. and contractors as necessary
- B.S. in Biology, Chemistry or related field with 3-5 years of experience in the Pharmaceutical or biotechnology
- Strong technical and communication skills: oral/written and listening. Personal competencies: self-awareness, integrity, team player, creative and flexible