Quality Assurance Specialist III - Packaging

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Job Description

Gilead Sciences is looking to hire Quality Assurance Specialist for the 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 crossfunctional teams during new product startups 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 fieldand MA/MBA/MS degree

• Prior experience in pharmaceutical industry

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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