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Quality Specialist/CAPA
Ref No.: 19-10736
Location: Campbell, California
Sunrise System Inc. is currently looking for Quality Specialist/CAPA in Campbell, CA with one of our top client.
Job Title: Quality Specialist/CAPA
Job Id: 19-10736
Location: Campbell, CA 95008
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
 
This position is responsible for one or more of the following duties or activities
  • Responsible for implementing and coordinating the QA review function ensuring all quality documents including batch records, QC records, and Validation documents, are reviewed in a timely manner.
  • The review function will also be responsible for generation of APR's, QA reports, and stability reports.
  • Responsible for implementing and coordinating quality systems including CAPA, deviation, change control, work order systems, Training, DCC and supporting any DSO or Corporate driven initiatives to enhance these systems.
  • Responsible for implementing and coordinating all activities relating to the control, distribution, maintenance and closure of GMP Quality documentation.
  • Identify and update appropriate procedures to assist in the management of QA system to ensure closure and approval.
  • Integration, preparation and distribution and review of product documentation, master batch records, media holds etc. to support operations and quality control departments consistent with corporate objective, GMP, and regulatory requirements.
  • Support the initiative in creating an embedded quality culture utilizing the following
  • Data driven decision making
  • Right First Time initiatives
  • Failure Mode Effect Analysis
  • Risk Assessment and HACCP Principles
  • Contributing to BSL improvement initiatives
  • BSL requires that each QA Specialist is proficient in multiple disciplines and areas including,
  • Commercial life cycle phases at Client sites.
Job Qualifications
  • Education
  • BS degree in Biology, Biochemistry or a closely related science discipline. 
Experience
  • Technical: 4 to 7 years of QA systems experience within Biotech or Biopharmaceutical environment.
  • Experience: IT Systems Strong user of Track Wise, Microsoft Project, Excel.
  • Experience: Regulatory Prefer experience in a GMP regulated environment
  • Experience: Analytical Prefer experience in protein chemistry. 
Note
  • Candidate have GMP experience working in a biotech or bio pharmaceutical industry.
  • Quality Systems experience (Deviations, Change Controls, Work Orders), and familiarity with review of GMP documents and ability to write technical reports. 
Contact
Abdul. A
Direct: (732) 272 0298 | Email: Abdul.A@sunrisesys.com
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com