QC Analyst GTAT
46 Galli Road Novato, CA 94949 US
The GTAT Analyst is responsible for providing support to activities related to lab and equipment management. The GTAT Analyst is responsible for supporting analytical method development, assisting with troubleshooting work and executing validation and transfer protocols, supporting the writing and reviewing of protocols and reports, supporting training to site QC, Contract Test Labs, and In Country Testing Labs in new techniques and methods. When necessary, the GTAT analyst may provide support in the preparation of regulatory submission documents. This role may include overtime and shift work.
- Adhere and follow cGMPs guidelines and procedures. Escalate non-compliance concerns to management.
- Monitor lab equipment for calibration needs, monitoring and tracking of issues related to instrumentation.
- Support the scheduled testing by ensuring the required reagents and glassware are stocked appropriately.
- Maintain the laboratory in an inspection-ready state
- Become competent in analytical methodologies, including: HPLC/UPLC, SDS Gels, UV Spectrophotometry, plate-based assays including ELISAs and cell-based Bioassays, PCR, etc.
- Testing of in-process samples, finished product, non-routine samples, packaging and stability, etc. in a cGMP environment as required.
- Assist with preparation of protocols, summaries, and reports, often for direct submission to pharmaceutical regulatory agencies
- Develop, optimize, validate and troubleshoot analytical test methods
- Act as technical resource (SME) and train other analysts in areas of expertise
- Evaluate results against defined acceptance criteria
- Conduct and document laboratory investigations and deviations to completion
- Support sample and record management for testing within the group and at CRO/CTO’s
- Manage shipment of materials and samples to other sites, CRO/CTO’s, or to in-country testing labs
- Interact directly with regulatory agency inspectors during audits
- Interface with other departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
- Other duties as assigned
- Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience or Associates of Science with at least 4 years of relevant laboratory experience.
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