QA Technical Associate

2 months ago


South Beloit, United States FurstProfessionals Full time

Quality Assurance Technical Associate


Qualified candidates must have:

  • Quality Assurance experience in the pharmaceutical industry or laboratory environment PREFERRED
  • Excellent cGMP knowledge
  • Strong organizational skills
  • Microsoft Word and Excel proficiency
  • Technical writing skills (be able to provide sample on request)
  • Ability to work independently and as part of the team
  • Bachelor’s degree in a science discipline – strong science background, chemistry preferred.


Responsibilities may include:

  • Analytical support/product development, formulation review, protocol approvals
  • Familiarity with CMC sections of abbreviated new drug applications
  • Document activation and distribution: SOPs, specifications, protocols, etc.
  • Analytical review: Must be able to review, interpret, and approve analytical reports
  • Stability data: Interpret results, trend analysis, and approval of stability data
  • Issuance and control of preventative maintenance documentation
  • Lab audits
  • Batch record maintenance and issuance
  • Final batch record review, release, and pedigree issuance
  • Support in various specialized software systems, such as Calibration program, documentation software, temperature monitoring, etc.
  • Incident and investigation writing
  • Technical support as needed.


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