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Quality Systems Specialist - l - Pharmaceutical

Position ID: DJM/CAquality
Location: San Mateo CA

Quality Systems Specialist - l - Pharmaceutical


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.



Westport One consistently ranks as one of the top 10 offices within the MRI Network system, which consists of more than 700 offices worldwide.

Our Contract Staffing division has been the National Office of the Year every year since 1995. We are the Contract Staffing "industry leaders" working specifically on contract and permanent positions within all industries. Key positions we fill are: General Office, Receptionists, Administrative Assistants, Secretaries, Executive Assistants, Transcriptionists, Customer Service Representatives, Human Resource Assistants, Data Entry, Accounts Payable, Accounts Receivable, Payroll, Bookkeeper, Medical Assistants, Medical Billing, Front Office, Back Office, Legal Secretaries, and Paralegals.


Any inquiries relating to this ad will be kept confidential.

To learn more about our organization please visit us at


To apply for this position, submit your resume by choosing one or more of the following:


  1. Email your resume in WORD format to . Please refer to job reference code DJM/CAquality in the subject line.

  1. Fax resume with cover letter to: 314-991-9586. Attention: Debbie Maul. Please refer to job reference code DJM/CAquality



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