Role Summary
This position is responsible for performing operations related to the manufacturing and/or packaging of drug products through equipment set-up, operation, clean-up and maintenance in compliance with regulatory requirements and company policies and procedures.
Responsibilities
- Responsible for learning the manufacturing and/or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc.
- Responsible for set up, changeover and operation of various manufacturing and/or packaging equipment including, but not limited to, mixers, granulators, dryers, mills, tablet compression, holder assemblers, blister formers and sealers, packagers and labelers.
- Responsible for cleaning of facilities, equipment and utensils as required following SOP’s and WI’s.
- Responsible for completing documentation as required in the manufacturing and/or packaging of product.
- Responsible for completing all training requirements and maintaining compliance with all assignments.
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
- Responsible for performing additional related duties as assigned.
Qualifications
- High School Diploma required
- Minimum 1 year’s experience operating equipment required
- SOP’s, cGMP’s, equipment and safety practices
- Standard Operating Procedures for process rooms and manufacturing area
- GMP compliance in a regulated work environment
- Manufacturing processes and equipment procedures
- Record keeping skills