QA Specialist I

仕事内容

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