QA Specialist I

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Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

Role and Responsibilities:
Provide Quality assistance and oversight of GMP manufacturing and facilities operations, as required. Performance of routine walkthroughs of manufacturing and facilities areas. Reviews and approvals Master Batch Records. Assists in the identification, initiation and investigation of deviation records that may result during day-to-day operations. Responsible for Lot release of manufactured products. Assures that the quality of manufactured products complies with all applicable regulations and guidelines. Assists with the review of executed manufacturing batch records and associated documentation required to release a production lot.

Essential Duties and Job Functions:

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
Participates in revising Standard Operating Procedures (SOPs) to ensure quality objectives are met.
Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
Reviews executed manufacturing batch records and associated documents for in-process and finished products.
Responsible for the review of lot disposition of manufactured products.
Works directly with operating entities to ensure that routine inspections of GMP areas such as the manufacturing area are conducted on a continuing basis as specified to enforce requirements and meet specifications.
Root cause analysis based on investigative findings and with consideration of the long-term impact of decisions.
Interfaces with manufacturing department to address product/process issues.
Provides QA oversight on deviations, CAPAs, and change managements.

Knowledge, Experience and Skills:

2+ years of relevant experience in a GMP environment related field and a BS OR 3+ years of relevant experience and an AA degree.
Prior experience in the pharmaceutical industry is essential, specifically support of Manufacturing QA.
Demonstrates knowledge of cGMPs.
Demonstrates knowledge of QA principles, concepts, industry practices, and standards.
Demonstrates excellent verbal, written, and interpersonal communication skills.
Biologics Analytical methods and techniques knowledge is a plus.

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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., Canada, Australia, Singapore, and Hong Kong 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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For Current Gilead Employees and Contractors:

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