Quality Control Analyst Job at Medix™, Madison, WI

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  • Medix™
  • Madison, WI

Job Description

Position Summary

  • The Quality Control Analyst II will be responsible for analytical testing and data verification supporting both late-stage clinical and commercial biosimilar products in cGMP-compliant laboratories and will also be expected to be engaged in continuous improvement initiatives to drive efficiency and effectiveness of Quality initiatives
  • A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays. A demonstrated ability to collaborate across multiple departments to drive timely resolution of projects, laboratory investigations, and process improvements is required.

Essential Duties & Responsibilities

  • Analytical testing to support product in-process, release, and stability programs.
  • Strong knowledge of cGMP, Quality Systems, and ICH / regulatory guidance.
  • Conduct, compile, and/or review Out of Specification lab investigations, deviations, and corrective and preventative actions plans.
  • Work with cross-functional teams to advance projects, maintain equipment, and authoring of documents and reports.
  • Train other analysts to perform laboratory procedures and assays. Participate in internal assessments and audits as and when required.
  • Performs other functions as required or assigned
  • Complies with all company policies and standards

Position Requirements and Qualifications

  • Bachelor’s degree in biotechnology, biochemistry, chemistry, or related field with a minimum of 3 years of experience in a pharmaceutical/biotech QC laboratory.
  • Alternatively, Master’s degree in above areas with 1 years of experience in a pharmaceutical/biotech QC laboratory or PhD in above areas with a minimum of 2 years of experience.

Experience:

  • Previous experience in a cGMP laboratory.
  • Strong background in protein chemistry and experience troubleshooting analytical results.
  • Demonstrated success at writing, revising, and complying with SOPs, protocols/reports, and QC methods.

Special Skills:

  • Demonstrated success working with techniques such as HPLC, SDS-PAGE, cell-based bioassays, capillary electrophoresis, SDS-PAGE, ELISA, and standard compendial assays.
  • Previous experience supporting regulatory inspections (e.g. PAI).
  • Familiarity with preparing regulatory dossiers and data packages for interactions with regulatory agencies.

Work Environment & Physical Demands:

  • Some time spent in an office doing office work (reading, writing, reviewing, and editing documents).
  • Significant amount of time spent in the laboratory.
  • Must be able to work extended hours or weekend hours as requested.
  • Must be able to lift at least 25 lbs.
  • Ability to work under pressure and meet deadlines.
  • High-paced environment structured to meet ambitious project goals

Job Tags

Weekend work,

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