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Senior Quality Assurance Specialist

2 months ago

Durham, North Carolina, United States KBI BioPharma Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at KBI Biopharma. The successful candidate will be responsible for ensuring the quality and compliance of our products, collaborating with cross-functional teams, and mentoring junior QA staff.

Key Responsibilities
  • Collaborate with Manufacturing, QA, and other departments to resolve production-related deviations and compliance issues in a timely manner.
  • Review and approve Deviations and CAPAs, ensuring compliance with cGMP requirements and company SOPs.
  • Support the development of training materials and training personnel to improve the Deviation/CAPA system.
  • Provide metrics to management as requested and mentor junior QA staff in deviation/CAPA review and approval.
  • Support client audits and regulatory inspections as required.
Requirements
  • Minimum BS in a scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
  • Experience with Quality Systems, including Batch Record review, supporting investigations, and CAPAs.
  • Knowledge of US, EU, and ROW cGMP guidelines required.
What We Offer

KBI Biopharma offers a competitive salary range of $80,000 - $120,000, depending on qualifications and experience. Our total rewards strategy includes an annual bonus structure, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days, and employee recognition programs.

We are an EEO/AA employer and actively seek to diversify our workforce. We are committed to providing a safe and healthy workplace and require all employees to provide proof of COVID-19 vaccination.