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QA Specialist I
Ref No.: 18-04089
Location: South San Francisco, California
Job Title: QA Specialist
Job Location: South San Francisco, CA
Job Duration: 6+ months contract

Job Description:

Position Overview
The QA Specialist in IMP Quality Systems and Compliance will be responsible for assisting our customers on the proper application of phase appropriate cGMP for IMP products (with an emphasis on small molecules).  The right candidate will be requested to build relationships with local and global team members comprised of scientists, engineers, regulatory and quality professionals.  Emphasis will be placed on driving for results and building relationships to ensure success. 
  
Essential Job Functions
  • Familiar with Quality System for change control and document management functions for GMP changes involving equipment, document, test methods, processes and specifications for IMP Small Molecule and Biologics.
  • Manage workflow through Trackwise and EDMS to ensure timely release of systems and documents.
  • Proactively identify, prioritize and assess quality systems compliance risks across the IMP network.
  • Manage Quality System for discrepancy and CAPA management for IMP customers
  • Perform routine Quality trend analysis of IMP discrepancies and audit of incident discrepancies.
  • Manage workflow through Trackwise discrepancy and CAPA systems
  • Assist with GMP self-inspection program for IMP manufacturing and testing areas including:
    • Maintenance of self-inspection audit plan and schedule
    • Coordination of self-inspection audit with other subject matter experts
    • Issue audit reports and track corrective action from audits.
    • Communicate to PTDQ-U leadership regarding compliance status
  • Maintain list of approved contract testing laboratories and corresponding Quality Agreements.
  • Participate in lab audits as needed
  • Mentor and supervise (as required) other Quality System staff members on Change Control, Discrepancy, CAPA, Self-Inspection, Quality Agreements and/or other related processes and projects.
  • May be requested to take on challenging assignments as an Individual Contributor (working with complex cross functional global teams).
  • Ensure proper department policies and procedures are in place to execute QS&C functions.
  • Provide input into the design and presentation of department performance metrics.
Non-essential Job Functions
  • Must be willing to train team members on specific assignments based on core experience.
  • Participate on Ad Hoc teams not related to primary role and responsibilities.
  • Provide input to the development of personal performance goals and departmental objectives.
  • Collaborate with Management to establish and meet targets and timelines 
Requirements
  • B.A., B.S., M.S degree (preferably in Life Science or Engineering) and at least 5 years' experience in the pharmaceutical, biopharmaceutical, device/combination or related industry, or an equivalent combination of education and experience.
  • Basic knowledge of US, EU and global cGMP requirements. 
  • Experience supporting production and testing of investigation medicinal products (IMPs)
  • Strong background in Quality Systems for IMP, Biologic and Combination products
  • Ability to interpret and relate Quality Standards for implementation and review.
  • Proven record of applying Quality, Compliance and Risk concepts to make sound technical decisions.
  • Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
  • Ability to communicate clearly and professionally both in writing and verbally.
 
Other Skills/Abilities
  • Several years' experience working with simple to complex Quality System software (Trackwise, SAP, LIMS)
  • MS Office Suite (Word, Visio, Excel)
  • Familiar with Google Docs.