QC Analyst

Company: Planet Pharma
Location: Novato
Posted on: July 30, 2022

Job Description:

Job Description:

• 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
• Perform Analytical testing incl: 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.
• 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 company 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 assignedRequirements:
  • BS in Biology, Molecular Biology, Chemistry, Biochemistry or similar fields.
  • 0 - 3 years experience.
  • Works well independently and in a team environment.
  • Focused and strong attention to detail.
  • Theoretical familiarity or experience with analytical methods, such as quantitative PCR / droplet digiatal PCR, ELISAs, SEC-HPLC, etc.
  • Familiarity or experience working with insect or mammalian cell lines not required, but preferred.
  • Motivated learner and ability to follow and adhere to procedures.

Keywords: Planet Pharma, Novato , QC Analyst, Professions , Novato, California