JOB TITLE: Manufacturing Associate
- Executes fundamental unit operations in Upstream Cell Culture manufacturing related to the manufacturing of bulk drug substance in a multi-product facility.
- Performs duties under limited supervision and according to standard operating and manufacturing procedures.
- 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 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.
- Preferable 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 intructions 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.
- High school degree, entry level position.
- Associates/bachelors degree or biotechnology vocational training preferred.
English Read, Write, Speak.
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