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QA Specialist III

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/
Key Responsibilities
The Specialist III Quality Assurance Analytical provides support for Contract Manufacturing and Contract Testing Laboratories (CxO Labs). This includes clinical and commercial release and stability testing, method validation and transfer, 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).
  • Gilead Quality Assurance Lead for method validation and transfer activities.
  • Gilead Quality Assurance Lead for major quality investigations/deviations/clinical complaints, may represent QA on Materials Review Boards, quality event escalation meetings, and effectively communicates and escalates major and/or critical events to upper management in a timely manner
  • 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.
  • As a quality functional site lead at CTLs support quality initiatives and responsible for providing quality metrics, trend reviews, and risk assessments.
  • Mentors junior staff on day to day activities.
Knowledge and Required Skills
  • Strong background in laboratory investigations (OOS, OOT, Atypical), deviations and associated CAPAs.
  • Strong background in analytical method validation.
  • 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.
Basic Qualifications
  • 6+ years of relevant experience in a GMP environment related field and a BS. OR 4+ years of relevant experience and a MS.
  • Prior experience in the pharmaceutical industry is required.