QA Specialist II

QA Specialist II

Job Responsibilities:

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Participates in developing Standard Operating Procedures to ensure quality objectives are met.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
• Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
• May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
• May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
• Works with Research and Development during new product start-ups and identifies routine checkpoints for new products and processes.
• Normally receives very little instruction on routine work, general instructions on new assignments.

Knowledge and Skills:

• Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates working knowledge of quality assurance systems, methods and procedures.
• Demonstrates knowledge of FDA / EMEA standards and quality systems,
• Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools for identifying and correcting deviations.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrates strong verbal, technical writing and interpersonal skills.
• Demonstrates proficiency in Microsoft Office application.

Typical Education and Experience:

• 4+ years of relevant experience in a GMP environment related filed and a BS.
• 2+ years of relevant experience and a MS.
• Prior experience in pharmaceutical industry is preferred.

For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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