QA Specialist II
QA Specialist II
United States - California - Foster City
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. Gileads 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 companys five core values. Thats 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
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.
You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/
The Specialist II Quality Assurance Analytical provides support for Contract Manufacturing and Contract Testing Laboratories (CxO Labs). This includes clinical and commercial release and stability testing, inspection support, and overall laboratory compliance.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Gilead Quality Assurance Lead for CxO laboratory investigations/deviations (exception events).
- Effectively communicates and escalates exception events to upper management in a timely manner, when required.
- Interfaces with CxO Management Teams to address site documentation and compliance issues.
- Monitors for, receives notification of, and initiates internal Gilead tracking records for CxO exception events and maintains associated metrics.
- Participates in writing, reviewing and approving controlled documents, as needed.
- May assist in compliance audits, as required. May interface with regulatory agencies, as required.
- Active participant on projects, initiatives, and process improvements.
- Normally receives little instruction on routine work and general instructions on new assignments.
Knowledge and Required Skills
- Strong background in laboratory investigations (OOS, OOT, Atypical), deviations and associated CAPAs.
- Proficient in application of FDA OOS Guidance, MHRA OOS Guidance and general QA principles, concepts, industry practices, and standards.
- Proficient in Root Cause Analysis Tools (e.g. Fishbone Diagrams and Failure Mode Effects Analysis, 5 Whys).
- Working knowledge of Risk Management Tools (e.g. root cause analysis, decision trees, risk registers).
- Possesses practical experience in a pharmaceutical GMP analytical testing laboratory. Experience with method validation preferred.
- Has proven analytical and conceptual skills.
- Demonstrates ability to effectively manage multiple projects/priorities.
- Demonstrates excellent verbal communication, technical writing and interpersonal skills.
- Demonstrates working knowledge and good proficiency in Microsoft Office applications.
- 4+ years of relevant experience in a GMP environment related field and a BS.
- 2 + years of relevant experience and a MS.
- Prior experience in the pharmaceutical industry is required.
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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 firstname.lastname@example.org for assistance.
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:
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