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Excellent Job Opportunity for the position of Quality Systems Specialist - I (3760)
Ref No.: 17-77435
Location: Foster City, California
Position Type:Contract
Start Date / End Date: 09/25/2017 to 03/22/2019
Job Title: Quality Systems Specialist - I
Work Location: Foster City, CA
Length of Assignment: 18 Months
Client: A Big Pharmaceutical Company

Job Description:
A contract resource is sought to support new building 357 Quality Assurance type activities at the Gilead Sciences Foster City, CA Site. The resource should have 2-3 years of prior experience in a regulated cGMP environment. Prior experience in the pharmaceutical /biotech sector is preferred. The resource should have a combination of experience in the Quality Assurance area along with knowledge of Facilities/Utilities design, maintenance, and validation. Additional proficiency in the use of Excel, Powerpoint, Maximo, and Trackwise software is needed.

Key job responsibilities are:
1. Development and generation of weekly/monthly QA group metrics. The metrics tracked will be validation document turnaround, Quality System records turnaround, and other group throughput data.
2. Performing first line review of unscheduled Maximo work orders and equipment job plans. The resource will be required to understand basic GMP requirements for calibration and maintenance of GMP utility and support systems such as HVAC, qualified gas systems, and purified/distilled water systems.
3. Performing periodic reviews of operational/maintenance procedures and forms as the quality assurance representative. The resource should have a working knowledge of key concepts that are required for GMP compliant standard operational procedures.
4. Performing quality reviews of validation life cycle documents such as system impact assessments, equipment risk assessments, user and functional requirements specifications, validation protocols and reports.
5. Supporting Quality Systems activities such as Deviations, Change Controls, and CAPA records. The resource should be familiar with the use of Trackwise software and how to review and participate in quality systems investigations and corrective action projects.

Interested candidates can share their most updated resume at or they can reach out to me on #973-967-3412 Ext: 3412