Executes routine unit operations in Visual Inspection as assigned related to the manufacturing of drug product in a multi-product facility.
- 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.
- 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 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.
PHYSICAL DEMANDS
- 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.
NOTE:
Worker required to clear
VISION TESTING
(acuity & color blindness) before starting assignment.
- High school degree + minimum 1 year work experience in GMP regulated industry
- Associates/Bachelor's degree or biotechnology vocational training preferred
Pay:
From $28.00 per hour Application Question(s): Do you have experience in GMP? Do you have experience in SOP? Are you comfortable as we required to clear
VISION TESTING
(acuity & color blindness) before starting assignment?
Work Location:
On the road