Description
We have an urgent opening for a "Quality on the floor" specialist with a global Biotech company here in the Bay Area. This is a 2nd shift position and there will be shift differential pay for the 1-930pm workday. The incumbent will spend a majority of their time on the manufacturing floor working closely with manufacturing personnel. More detailed responsibilities are as follows:- Monitor GMP practices and report errors, deficiencies, discrepancies and observations to management in real time.
- Work closely with diagnostics manufacturing departments to identify improvement opportunities
- Track and trend compliance/quality issuesand advise managment of those requiring action
- Review manufacturing and testing records, deviations and document changes
- Determine appropriate metrics for reporting to senior management, and present during quality reviews
- Perform scheduling and activity coordination for Quality on the floor department
- Participate in Failure Mode and Effect Analysis (FMEA) and Operational Quality Risk Assessment processes
- Utilize Operational Excellence tools to assess area procedures and practices
Minimum requirements
- B.S./B.A. in Biological Sciences
- 6-8 years of related experience with a minimum of 6 years of GMP/ QSR/ISO and /or QA related experience.
- 3-4 years of pharmaceutical manufacturing or QA on the floor experience
- Certified in Six Sigma/ Lean
- Experience in the following areas: fermentation, purification, Quality Control.
- Excellent written and interpersonal communication skills
If you feel that you are qualified and interested in a 2nd shift position, please respond to b.ross(@)realstaffing.com. Thank you for your interest
To find out more about Real please visit www.realstaffing.com