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Quality Systems Specialist II

Gilead Sciences

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Location: Foster City, CA Posted Date: 4/29/2013 Position Type: Full time Job Code: 12382 Required Education: Bachelors Degree

Description

Gilead was founded in 1987 in Foster City, California. In 25 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 5,000 employees in offices across four continents. Today, our research and development effort is the largest it has ever been, with more than 75 Phase 2 and 3 clinical studies evaluating compounds with the potential to become the next generation of innovative therapies for HIV, hepatitis, serious respiratory, cardiovascular and metabolic conditions, cancer and inflammation. In 2012, Gilead’s annual revenues reached approximately $9.7 billion, and in 2009, BusinessWeek ranked Gilead #1 in its annual listing of the 50 Best-Performing Companies. For more details, go to: http://www.gilead.com/corporate_overview

Specific responsibilities
- Support commercial quality systems activities (quality reviews, change control, and so forth) to ensure compliance with applicable Gilead procedures and pharmaceutical regulatory requirements, under supervision
- Organize, manage, and participate in cross-functional projects and activities
- Assist in developing high-quality reports based on SOPs and management expectations
- Work on multiple assignments, in a fast-paced environment and maintain quality output
Required skills
- Strong technical writing and review skills with attention to details
- Strong working knowledge and application of cGMPs
- Strong working knowledge of quality assurance systems, concepts, principles, industry practices, and standards
- Strong teamwork cooperation to achieve common goals
- Proficient with Microsoft WORD and EXCEL
- Proficient with Quality Management System (QMS) and Enterprise Quality Management Software (TrackWise EQMS)
- Proficient with Laboratory Information Management Systems (LIMs)

Essential Duties and Job Functions:

- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
- Assists with the review of manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Normally receives very little instruction on routine work, general instructions on new assignments.
- Provides guidance and technical knowledge to more junior staff.

Requirements

- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs).
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Demonstrates knowledge of FDA / EMEA standards and quality systems.
- Demonstrates good verbal, written, and interpersonal communication skills.
- Demonstrates 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.
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