QA Specialist III

Gilead Sciences • El Segundo, CA

3d • $107,185 - $138,710

About The Position

The QA Specialist III supports quality assurance and regulatory compliance across manufacturing and related operations. The role maintains programs and processes to ensure product quality and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), and reviews routine manufacturing, environmental monitoring, and quality control data for in-process and finished products. It applies quality principles and regulatory standards, including FDA and EMEA requirements, and works with manufacturing, distribution, maintenance, Research and Development, and contract manufacturers. The position normally receives no instruction on routine work and general instructions on new assignments.

Requirements

• At least 6 years of relevant experience in a GMP-environment-related field and a BS or BA, or at least 4 years of relevant experience and an MS.
• Proficiency in GMPs and/or GLPs.
• Proficiency applying QA principles, concepts, industry practices, and standards.
• Thorough knowledge of FDA and EMEA standards, quality systems, and their interface with functions such as manufacturing, distribution, and maintenance.
• Strong knowledge of Six Sigma, LEAN, and root cause analysis tools for identifying and correcting deviations.
• Audit, investigation, and report-writing skills.
• Strong verbal, technical writing, and interpersonal skills.
• Proficiency with Microsoft Office applications.

Nice To Haves

• Prior experience in the pharmaceutical industry is preferred.

Responsibilities

• Perform activities to ensure compliance with applicable regulatory requirements.
• Participate in developing Standard Operating Procedures (SOPs) to meet quality objectives.
• Maintain programs and processes that support product quality and compliance with GMPs and GLPs.
• Review routine manufacturing, environmental monitoring, and quality control data for in-process and finished products.
• Develop solutions to complex problems, identify deviations from accepted practice, and evaluate impact assessments as required.
• Work with operating entities to ensure inspections, statistical process control analyses, and audits are conducted as specified.
• May facilitate external audits and inspections and support implementation of agreed corrective actions.
• Participate in writing annual product reviews.
• May conduct or coordinate investigations and recommend corrective and preventive actions (CAPA) related to manufactured products.
• Work with Research and Development during new product start-ups and identify routine checkpoints for new products and processes.
• May assist with compliance audits.
• Interface with contract manufacturers to address documentation and compliance issues.
• Write and/or implement changes to controlled documents, including SOPs, specifications, and methods.

Benefits

• Discretionary annual bonus may be available.
• Discretionary stock-based long-term incentives may be available, with eligibility varying by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior