A Quality Specialist is needed for a long-term contract position at a major biotech company in Northern California - Partner with inVentiv Health and TEAMSCI on this awesome opportunity!
Job Duties:
1. Maintain and monitor document control system and equipment record status in compliance according to CAP/CLIA/CA/NY and other regulatory agencies.
2. Prepare for and participate in internal audits of the CLIA lab and supporting systems. Maintain schedule of planned quarterly audits.
3. Provide assistance to the CLIA lab for all CAPA and nonconformance investigation and resolution. Oversee the CAPA and Nonconformance management systems.
4. Provide assistance to maintain high quality standards and change control during new test launch, LIMS updates, and all process changes.
5. Maintain training and competency records. Ensure new hires have completed all required tasks. Provide assistance to distribute and collect Continuing Education records. Assist in development of updates to the training and competency program.
6. Support administration of the environmental monitoring system. Provide user assistance and back up support to engineering services during upgrades or moves.
7. Assist with / manage projects to improve the effectiveness and efficiency of the existing quality system
8. Maintain records and proper documentation for Quality Meetings including preparation and distribution of performance metrics.
9. Communicate and escalate any issues or concerns to the QA Manager.
Education and Experience:
• Bachelor’s degree in Chemistry, Biological Sciences or related field, or equivalent combination of education and work-related experience.
• 1 to 2 years in the diagnostics or pharmaceutical industry dealing with quality.
• Preferred: 3 to 4 years in the diagnostics or pharmaceutical industry dealing with quality.
• Preferred: Experience working with CLIA, CAP, and NYS regulations / standards for operation of a Clinical Laboratory
Work location: San Jose, CA