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QA Specialist II

Company: Gilead
Location: San Mateo
Posted on: November 14, 2021

Job Description:

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.Job DescriptionJob ResponsibilitiesPerforms 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 (GMPs) and Good Laboratory Practices (GLPs).Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.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 facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed.Participates in the writing of annual product reviews.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.Interfaces with contract manufacturers to address documentation and compliance issues.Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.Knowledge & Skills:Demonstrates understanding and application of GMP principles, concepts, best practices and standards in the US and internationally.Demonstrates general knowledge of pharmaceutical manufacturing.Demonstrates excellent verbal, written, and interpersonal communication skills.Interface with other functions like manufacturing, supply chain and analytical.Demonstrates strong knowledge of root cause analysis tools used for identifying and correcting deviationsTypical Education & Experience:4+ years of relevant experience and a Bachelor's degree in science or related fields. OR 2+ years of relevant experience and an advanced science degree such as MS.Knowledge and experience in quality assurancePharmaceutical experience 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 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.For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.

Keywords: Gilead, San Mateo , QA Specialist II, Other , San Mateo, California

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