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QC Analyst

Marin Metro Area, CA

Posted: 06/26/2019 Job Type: Scientific Job Number: JN -062019-25147
PURPOSE
The QC In-Process department 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, Total Organic Carbon, microbial identification and challenge studies, aseptic techniques, and method validation.

Job Duties:
  • Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with department procedures.
  • Organize, maintain, track and archive department documents and records while adhering to the document lifecycle procedures and in accordance with the records retention schedule.
  • Execute select 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. Assist with the compilation and verification of trend analysis reports.
  • Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and 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.
  • Provide on call coverage for action level conditions to support oversight of QC laboratory equipment functionality.
  • Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
  • Perform other responsibilities as deemed necessary.

Skills:
  • The QC analyst should have the ability to prioritize, manage time well, multitask and troubleshoot. Strong interpersonal, communication and customer service skills are also essential because the QC analyst will regularly communicate with internal and external business partners.
  • Must have excellent record keeping, written and verbal skills.
  • Ability to perform most tasks without supervision.
  • Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices is a plus.
  • Able to lift up to 25lbs
  • Computer literacy is required, proficiency with Microsoft Word and Excel is essential.
  • Must have excellent record keeping, written and verbal skills.
  • Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

Education:
  • Bachelor of Science in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience
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