BS preferred. BA Acceptable. Job experience equivalents considered.
FMSA training or HACCP training is an advantage. Will be provided with acceptance if not in hand.
Two years experience in either the production or quality assurance / quality control side of a regulated manufacturing operation, meaning food, pharmaceutics, nutraceutics, biologics, cannabis.
Organize and maintain the basic quality system for the operation in Oakland, which entails the following:
- Issue all forms and batch records.
- Receive all forms and batch records after use and “mass balance” against the number issued.
- Review filled documents and “positively release” batches of product by confirming completeness and conformance of records with established processes and procedures.
- Drive the investigation of Deviations and Complaints.
- Organize document storage for all investigations and paper systems.
- Retain documents for specified periods.
- Organize and maintain the change control system, including document changes, equipment changes, and facility changes.
- Establish, with help, and maintain system of statistical process control on critical process parameters as identified by development and testing.
- Represent the quality unit in new product development, facility development, equipment acquisition.
- Participate in or lead audits by regulatory bodies, including BCC, FDA, once applicable, CDPH, Fire Marshal, etc.
- Lead response to audit findings.
- Develop rework plans.
- Submit rework plans to BCC.
Be able to lift 50 lbs.
Expect to work alongside production in slow periods, performing non-critical tasks such as labeling, counting, reworking labels, etc.