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Quality Systems Specialist - I

San Mateo, CA 94404

Posted: 01/30/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 536044 Is job remote?: No Country: United States

Job Description

Pay Rate Range: $20-27/hr

Seeking a highly motivated individual to join us as a Quality Systems Specialist I in our clinical cell therapy production center located in Santa Monica CA. The Quality Systems Specialist I will be responsible for providing support of clinical manufacturing. In this role you will be responsible for daily routine tasks of Quality Systems for cell therapy products. You will report to the Associate Director Quality Systems and Compliance.

Responsibilities (include but are not limited to):
  • Perform document control activities including issuance and verification of manufacturing lots
  • Perform all activities around scanning and archiving documents for the site
  • Provide trainings to new hires as required for management of documents
  • Be an advocate on the new phase appropriate approach of manufacturing at the clinical site
  • Gather metric information for use in continuous improvement of areas of responsibility
  • Generate data reports on required to be presented at Tier 4 and 5 meetings and at QMRs
  • Develop, revise and review SOPs and Work Instructions
  • Support proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
  • Support site training needs and work with the team to address these concerns
  • Support process improvement projects and investigations.
  • Support audits
  • Monitor the GMP systems currently in place to ensure compliance with documented policies
  • Perform other duties as assigned

Basic Qualifications:
  • Bachelors Degree and 4+ years experience in Quality OR
  • AA Degree and 5+ years experience in Quality OR
  • High School Degree and 6+ years experience in Quality

Preferred Qualifications:
  • The ideal candidate is familiar with analyzing and reporting results and metrics using graphical presentation.
  • The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas.
  • Ability to learn quality systems and regulatory requirements (21 CRF Part 11/210/211).
  • Knowledge of GMP, SOPs and quality control processes preferred.
  • Identifying, writing evaluating and closing OOSs and investigations.
  • Proficient in MS Word, Excel, Power Point and other applications
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
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