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Sr. Specialist, Quality Systems

Job Description Specific Responsibilities: 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/ Essential Functions: Will provide on the floor QA oversight and support to ensure compliance of GMP activities throughout the site. Direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address compliance issues and questions real time. Ensures adherence to proper escalation when non-conformances are identified as outlined per applicable procedures.  Serves as a resource for compliance, escalation and corrections. Ensure departmental compliance to procedures, gmp records and associated forms . Ensures  documentation is recorded in accordance with ALCOA principles. Mentors trains and coordinates activities of other QA personnel, including organizing and prioritizing daily tasks. Identify, track, prioritize and correct inaccuracies/improvements. Knowledge, Experience & Skills: 7+ years of relevant experience in a GMP environment related field and a BS or BA. 5+ years of relevant experience and a MS. Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs). Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards. Demonstrates ability to effectively manage multiple projects/priorities. Has proven analytical and conceptual skills. Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes. Demonstrates excellent verbal communication, technical writing and interpersonal skills. Demonstrates strong proficiency in Microsoft Office applications. Shift Thursday, Friday, Saturday- 3x12 shift (4pm to 4am) Rotation - Every other Sunday (4pm to 4am) If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: About Gilead: Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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 R0005844
Salary Range: NA
Minimum Qualification
8 - 10 years

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