QC Investigator

Location: College Station, TX
Department: Azzur Austin, LLC

Job Description

We at Azzur Group are looking for an experienced QC Investigator to immediately join our Azzur Consulting: Austin team. The QC Investigator is an FTE project based role. This position is responsible for conducting OOS investigations, trending site Environmental Monitoring and Critical Utility data and authoring quarterly and annual trend reports, completing data review for micro data, and acting as a QC Microbiology SME.


ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Act as QC lead investigator to close major/minor QC Investigations
  • Provides OOS investigational support.
  • Review technical transfer, qualification and validation protocols as needed.
  • Meet with clients to report on protocol and test method status, deviation status, etc.
  • Technical Writing to include:
    • Writes and revises Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation as appropriate.
    • Qualification protocols
    • Transfer Protocols
    • Creating manuals for processes/activities
    • Sample plans (support & edit)
    • Assisting and initiating closure of deviations, CAPAs and Change Controls
  • Reviewing Methods for accuracy: HPLC, Chromatography (Ion Exchange, SEC, RP-HPLC, Residual Analytes)
  • Reviews data obtained for compliance to specifications and reports excursion/out of specifications.
  • Maintain compliance with GMP and GLP guidelines
  • Assist and support all quality control activities and deliverables as assigned
  • Demonstrate a "right-first time" attitude and attention to detail
  • Perform other duties as assigned


QUALIFICATIONS AND REQUIREMENTS:

  • Bachelor’s Degree in science or engineering required, with a minimum of 5 years of pharmaceutical, life sciences, or medical device industry experience in manufacturing or QC
  • Proven ability to manage timelines and meet internal/external deadlines
  • Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals
  • Project management experience a plus


Apply Now

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