Quality Assurance Specialist III - Packaging

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

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Job Requisition  R0044780

Full Time/Part Time Full-Time

Job Level Associate

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