Senior Quality Assurance Professional

6 days ago


Durham, North Carolina, United States KBI BioPharma Full time
About Us

KBI BioPharma is a leading biopharmaceutical company that strives to deliver high-quality products and services.

Job Description

We are seeking an experienced Deviation Specialist to join our team. The successful candidate will be responsible for ensuring the timely review and approval of Deviations, CAPAs and ECs, in accordance with cGMP requirements and company SOPs.

Key Responsibilities
  • Collaborate with cross-functional teams to ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks (ECs) for Deviations.
  • Review and approve Deviations, CAPAs and ECs, ensuring compliance with cGMP regulations and company policies.
  • Provide training and certification to QA staff on Deviation/CAPA review and approval procedures.
  • Support the development of training materials and training personnel to improve the Deviation/CAPA system.
  • Attend relevant operational and project meetings to ensure effective communication and collaboration.
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.
Compensation

The estimated salary for this position is $90,000 - $110,000 per year, based on current industry standards and market conditions.

Benefits

We offer a comprehensive benefits package, including medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days, and employee recognition programs.



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