Manufacturing Visual Inspection
Job Description
Job Description
Job Description:
· 12-months contract – possible extension based on performance & budget
· 2nd Shift: Mon-Fri; 2pm to 10:30pm.
· Executes routine unit operations in Visual Inspection as assigned related to the manufacturing of drug product in a multi-product facility.
Required Skills:
· High School Diploma or GED is required.
· Minimum 1 year or more work experience in GMP/cGMP/FDA regulated industry.
· Experience as a Quality Inspector, Inspection Technician, Visual Inspection, Quality check is required.
· Must be able to read and see clearly.
· Any experience in back of the line Packaging or Filling is preferred.
Other Skills:
· 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.
Responsibilities:
· 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.
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.