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Quality Assurance Specialist III - Packaging

United States - California - Foster CityQualityRegular
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Job Description

We are looking to hire Quality Assurance Specialist for our Packaging group.

Job Responsibilities:

  • Reviews and approves CMO (Contract Manufacturing Organization) master batch records.

  • Performs review of primary and secondary packaging lot packets.

  • Performs review/approval of various GMP packaging documents related to CMO operations.

  • Executes QA release of packaged products for further processing or distribution.

  • Interfaces with CXOs to provide QA oversight of routine manufacturing/packaging activities.

  • Performs a variety of activities to ensure compliance with applicable regulatory requirements.

  • Adheres to programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

  • Reviews manufacturing/packaging control data for in process and finished products with guidance from senior colleagues.

  • Authors applicable sections of annual product reviews related to manufacturing/packaging of product and reviews applicable CMO annual product review reports.

  • Supports CXO investigations and may lead Gilead investigations to ensure robust root cause assessment and identification of corrective and preventive action (CAPA).

  • Works with cross-functional teams during new product start-ups and product launch, with guidance from senior QA colleagues.

Knowledge and Skills

  • Demonstrates working knowledge of current Good Manufacturing Practices (GMPs).

  • Demonstrates working knowledge of Quality systems and processes.

  • Demonstrates knowledge of FDA / EMEA standards and guidelines.

  • Demonstrates basic knowledge of six sigma, LEAN and/or root cause analysis tools used for identifying and correcting deficiencies.

  • Demonstrates investigation skills and technical writing skills.

  • Demonstrates effective verbal, written, and interpersonal communication skills.

  • Demonstrates working proficiency in Microsoft Office applications.

Education and Experience

  • 5+ years of relevant experience in a GMP environment or related field and BA/BS degree OR

  • 3+ years of relevant experience in a GMP environment or related field and MA/MBA/MS degree

  • Prior experience in pharmaceutical industry