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Quality System Spec II

Location: Hercules, CA, United States
Job # 11958331
Date Posted: 02-22-2019
Title: Quality System Spec II
Start date: ASAP
Location: Hercules, CA 94547
Pay rate: $40/hr.
Temp to hire

Seeking a quality systems specialist to join the Northern California QA team.  This position will support a variety of quality systems functions including non conformance/deviations, change management, batch record review, procedure review  and validation/verification activities. 
  • Support the Quality Notification process (Non conformance/Deviations) and related CAPA activities, including interfacing with multiple business division product lines.  Position will be responsible for leading and or coordinating Quality Notification activities during investigation, follow-up and related CAPA activities.  Supports investigations including but not limited to assessing risk, investigating root cause and implementing effective long-term corrective actions to prevent recurrence of identified quality issues. 
  • Review and approve change control documentation in support of GMP operations, including but not limited to product, equipment, facility and process changes.
  • Review batch records and release product batches in SAP within a specified time frame.
  • Review instrument service repair documentation and related service records
  • Ensure adherence to internal procedures and industry/regulatory expectations.
  • Support a wide range of continuous and process improvement initiatives, including creating process flow maps, procedures and training materials.
    • Associates 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 ISO 13485 and FDA 820 requirements.
    • Experience with non-conformance management  and change management within a regulated environment.
    • Preferred experience working in a global multiple-site company with multiple quality systems.
    • Experience with SAP and QMS databases (ie. EtQ, Trackwise).
Please submit your resume in a PDF or Word format for immediate consideration.  #ZR
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