Quality Systems Specialist-Contract-Biotech-East Bay

Quality Systems Specialist to assist the Northern California Quality Assurance Operations team in support of manufacturing activities including, supporting product non conformance investigations and deviations, product quality holds as well as batch record and product release.

 Responsibilities:

 The Quality Systems Specialist will play a key role in supporting various manufacturing activities across several manufacturing locations on the Hercules campus.  The position will entail the following:

  • Support activities related to batch record review, product release, assisting with document inquiries and SAP transactions.
  • Review and compile device history records for accuracy and completeness, and to ensure adherence to in-house specifications and regulatory requirements and document deviations as appropriate.
  • Supporting product and process non-conformance and deviation management and product quality holds.
  • Administration of investigation and deviation systems for tracking status, follow-up and liaison with applicable department investigation assignees.
  • Maintain and archive controlled documentation and completed quality records as needed.

Qualifications: 

  • Associate degree or equivalent in Biology, Chemistry, or related field.
  • 2+ years experience in a regulated manufacturing industry or equivalent combination of education and experience.
  • Understanding of GMP and quality system standards as they apply to products manufactured with a working knowledge of device/drug/biotech manufacturing processes.
  • Detail-oriented and ability to multitask.
  • Decision making, time management, organization, communication, leadership, and computer skills.
  • Experience with QMS Databases (i.e., EtQ, Trackwise).
  • SAP experience a plus.

 

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