Compliance Specialist II, Pharma (s570)

  • Contract Duration: 3-6 Months
  • Manufacturing
  • Framingham, MA

Website Lenox Executive Search

Job Description:

  • Perform reviews/audits of Quality Control data necessary to ensure the compliance of procedures to in-house specifications and regulation.
  • Conducts review of testing results, logs and instrument audit trails.
  • Review documentation against established product specifications and procedures.
  • Interpret complex, explicit documentation to ensure quality standards and compliance, may revise when necessary.
  • May provide training to new employees.
  • Releases final results of batches to Stability and QA and may compile Certificates of Analysis.
  • Work under only very general supervision.
  • Work is reviewed for soundness of judgment and overall adequacy and accuracy.
  • Contribute to the completion of organizational projects and goals.
  • Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
  • Frequent internal company and external contacts.
  • Represent organization on specific projects.
  • May interact with auditors.

Education and Experience:

  • Bachelor’s Degree & 3 years’ of experience OR Associate’s Degree & 5 years of experience in Quality or cGMP operations.
  • Experience with GC, FTIR, Atomic Absorption, UV Vis Spectroscopy and wet Chemistry.
  • Experience with Empower software
  • Excellent communication skills both written and verbal.
  • Strong critical thinking ability.
  • Effective time management and organizational skills.
  • Strong attention to detail and ability to work with others in a group environment
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– The Lenox Executive Search Team