QA Specialist II

QA Specialist II
United States - California - Oceanside

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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 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.

Working in Quality Assurance at Gilead:

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.

Job Summary:

Provide Quality assistance and oversight of laboratory and warehouse operations, as required. Performance of daily walkthroughs of laboratories, storage, and warehouse areas. Reviews and approvals ancillary documentation associated with Lab testing including logbooks, forms, raw data, etc. Assists in the identification, initiation and investigation of deviation records that may result during day-to-day operations. Responsible for quarantine material storage as well as raw material inspection and release of raw materials. Assures that the quality of manufactured products complies with all applicable regulations and guidelines. Assists with the review of laboratory 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 developing 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 Analytical, environmental monitoring, and quality control data for in-process and finished products.
• Responsible for review, final release, and CofA creation for manufactured products and raw materials.
• 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.
• Root cause analysis, corrective action based on investigative findings and with consideration of the long-term impact of decisions. Problem solving, detail analysis and recommendations on path forward.
• Interfaces with contract testing laboratories to address and resolve more complex product/process performance issues.
• Provides QA oversight on laboratory and warehouse deviations, change management, and CAPAs.
• Works with Research and Development during new product start-ups, and identifies checkpoints for new products and processes.
• Preforms review of analytical method validation and analytical instrumentation validation protocols and reports.
• Normally receives very little instruction on routine work, general instructions on new assignments.

Knowledge, Experience and Skills:

• Bachelor's degree and 4+ years of relevant experience in a GMP environment related field OR Master's degree and 2+ years of relevant experience.
• Prior experience in the pharmaceutical industry is essential, specifically support of QC or Analytical operations.
• Demonstrates in-depth knowledge of cGMPs and/or GLPs.
• Demonstrates in-depth 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.

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., 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.​

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our 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.






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