Responsibilities:
- Excellent employment opportunity for a Manufacturing Visual Inspection in the Fremont, CA area.
- Duties: Executes routine unit operations in Visual Inspection as assigned related to the manufacturing of drug product in a multi-product facility.
- 2nd Shift: Monday to Friday, 2:00PM-10:30PM
- Performs duties under limited supervision and according to standard operating and manufacturing procedures.
- Executes independently with adequate training, complex fundamental operations as visual inspection, advance visual inspection, palletizing, cleaning, inspection hood prep for operations, BioMES Operations and Exceptions.
- Performs internal support duties including assisting drug product filling and packaging.
- Executes independently with adequate training fundamental operations
- Logistics Coordination
- Batch record executions
- Equipment use logs
- Work order initiation and tracking
- Support Projects
- Support Creation/Maintain Training Kits 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).
- Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
- Contributes to Quality activities such as supporting investigations, corrective actions and area walk throughs.
Experience:
- High school degree + minimum 1 year work experience in GMP regulated industry
- Associates/Bachelor's degree or biotechnology vocational training preferred1 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 and manufacturing execution systems (MES).
- Ability to read and understand SOPs and 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.
- Must be able to read and see clearly.
- Duties of this position may require the incumbent to exert some physical effort.
- Lifting requirements may vary dependent on the drug product manufacturing visual inspection area activity.
- Weight is typically no more than 25 pounds.
- Employees required to participate and have acceptable result from vision testing including color blindness.
Job Type: Contract
Work Location: In person
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