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Quality Assurance Senior Associate

2 months ago

Greenwich, Ohio, United States Collabera Full time
Job Description

Collabera is seeking a highly skilled Quality Assurance Senior Associate to join our team. As a Quality Assurance Senior Associate, you will be responsible for ensuring the quality of our products and services.

Key Responsibilities:
  • Provide quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
  • Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
  • Perform review and approval of cGMP processes, procedures, documents and records.
  • Ensure that changes that could potentially impact product quality are assessed according to procedures.
  • Review executed batch records, attachments, and area logbooks.
  • Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Alert senior management of quality, compliance, supply and safety risks.
  • Complete required assigned training to permit execution of required tasks.
Requirements:
  • Master's degree OR Bachelor's degree and 2 years of experience (in QA or MFG) OR Associate's degree and 6 years of experience (in QA or MFG).
  • Academic background in Sciences.
  • Experience working in Quality Assurance in either Biotech or Pharmaceutical industry.