Hercules,

Quality Systems II

Quality System Specialist II

Location: Richmond, CA. (On-Site)

6 month Assignment (Great potential to extend)

Pay Rate: $34-$43/hr.

Schedule: M-F 8-5pm

On behalf of our client a medical device company, we are seeking for a Quality System Specialist II that will play a role in supporting the Northern California Quality Assurance team. Including investigations of product non-conformance and deviations, manufacturing activities, conforming material, batch record and CoA review and release. As well as in the support of documentation and quality record updates to reinforce the Quality Management system.

Job Responsibilities:

  • Support batch release for LSG mfg sites.
  • Support Veeva integration for NorCal (Change Control, Nonconformance Management).
  • Verification of Change Control activities.
  • Rapid containment of product quality issues (either from manufacturing issue or a customer complaint issue).
  • Audit preparedness, to reduce audit findings.

Education and Experience:

  • 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/ISO regulations (ISO 13485, MDSAP, FDA 820/210/211).
  • Working knowledge of device/drug/biotech manufacturing processes.
  • Proficient in Microsoft Office, Visio and Excel
  • Salesforce and SAP experience is a plus

  • Max. file size: 300 MB.