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Quality Systems Specialist Job Description

Position: Quality Systems Specialist

Location: Hercules CA USA 94547

Skills: GMP, QMS Database, Trackwise, SAP a Plus, Manufacturing

Description:

Responsibilities 

  • The Quality Systems Specialist will play a key role in supporting various manufacturing activities across several manufacturing locations on the company campus. 
  • Activities will include 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 assignee's. 
  • Perform activities related to batch record review, product release, assisting with document inquiries, SAP transactions, and posting of CofA's.
  • 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. 
  • 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 by Bio-Rad 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 is a plus.

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