QA Specialist I

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As a QA Specialist I, you are responsible for: Key Responsibilities: · Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs). · Compile and verify all batch related documents are complete to support lot release. · Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with minimal guidance from senior colleagues · Elevate any issues affecting lot manufacturing or release to Management in a timely manner · Ensure that any Deviations in executed Manufacturing Production Records are appropriately identified · Ensure that manufacturing Deviation, Change Management, and other records to support lot release are acceptable. · Prioritize lot release of various product types (sterile/parenteral, solid dose, finished goods, and clinical) · Gather metrics related to lot release, quarterly business reviews, and annual product reviews · May develop training programs related to Batch Record Review and Release processes · Participate in revision of Batch Record Review and Release SOPs/forms Basic Qualifications: · Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs). · Demonstrates basic knowledge of FDA / EMEA standards and quality systems. · Demonstrates good verbal, written, and interpersonal communication skills. · Demonstrates working knowledge in Microsoft Office applications. · Specific Education & Experience Requirements: · BS with at least 2 years of relevant experience in a GMP environment. OR AA degree with at least 3 years of relevant experience in a GMP environment. Preferred Qualifications: · At least 4 years’ of relevant experience in Quality Assurance, Quality Control, or a cGMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility · Working knowledge of cGMP, quality systems and regulatory requirements (21 CRF Part 11/210/211, etc.) practices/principles · General knowledge of aseptic manufacturing processes · Experience with information systems (LIMS, MES, Oracle EBS) · Experience with internal and external audit · Experience with Health Authority Regulations and Validation practices/principles · Knowledge of IQ/OQ/PQ Share: Job Requisition ID R0045370 Full Time/Part Time Full-Time Job Level Associate Click below to return to the Gilead Careers site Click below to see a list of upcoming events Click below to return to the Kite, a Gilead company Careers site

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