6701 Kaiser Drive Fremont, CA 94555 US
- Executes independently with adequate training non-complex fundamental operations as parts cleaning, weigh and dispense, equipment prep, kits assembly, and staging. Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
- Executes with oversight of qualified staff fundamental tasks as CIP and SIP of BR's, tanks, manufacturing equipment as well as media or buffer prep and transfer into tanks and bags
- Daily analytics and maintenance of analytical equipment. Cleaning and setup of equipment
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established by site.
- Reports abnormalities and deviations in a timely and accurate manner.
- Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
- Maintains production areas according to predefined standards (5s).
- Keeps own training on track and trains other technicians and associates on operations.
- Contributes to Quality activities as investigations and area walk-throughs.
- Experience working with established GMP procedures and bulk manufacturing is a plus. Technical knowledge of manufacturing systems, methods and procedures.
- Understanding of purification/cell culture processes. Possess effective troubleshooting skills with equipment and/or process.
- Preferable one (1) or more years of experience in cGMP regulated industry
- Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first-time mindset.
- Strong written and verbal communication skills.
- Ability to work with computer-based systems.
- Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP standards.
- Ability to work as part of a high performing team and collaborate effectively with staff.
- Working in a highly regulated environment following all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance policies.
- Required to work according to given schedules in a 24/7 shift structure and flexibility to adapt working schedule upon prior given notice.
Pay range 20-25/hr
Salary will be commensurate with experience
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.