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Quality Assurance Analyst

Indianapolis $85,000 - $90,000 Permanent

Responsibilities:

  • Generate and review supplier evaluation documentation, including evaluations, questionnaires, and audit reports.
  • Manage and track Supplier Corrective Action Request (SCAR) processes to ensure effective resolution.
  • Draft and review quality agreements between suppliers and INCOG.
  • Review and evaluate material specifications.
  • Lead internal audit planning and track mitigation actions.
  • Support and assist with external and third-party audits.
  • Assist with recall and complaint management processes.
  • Contribute to Annual Product Review activities.
  • Oversee multiple projects simultaneously in a fast-paced environment.

Qualifications:

  • Bachelor’s Degree in a related field (e.g., Chemistry, Biology, Biochemistry, Microbiology).
  • Minimum of 5 years of biopharma industry experience with increasing responsibilities in supplier quality management or supply chain quality.
  • At least 5 years of experience in internal audit activities.
  • Minimum of 2 years of experience in biopharma activities related to recalls, complaints, and Annual Product Reviews.
  • Strong written and verbal communication skills.
  • Proficiency with computer systems, including SAP and reporting/data analysis software (e.g., Word, Excel, Visio, JMP, Minitab).
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