QA Specialist III

Job Description

Knowledge:

• 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.

Basic Qualifications:

• 4+ years of relevant experience in a GMP environment or related field and a BS or MS degree.

OR

• 5+ years of relevant experience and an AA degree.

OR

• Prior experience in pharmaceutical industry.

Specific 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 review of packaged products intended 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.

• Normally receives no instruction on routine work, general instructions on new assignments

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.