Gown Qualified Operator / Environmental Monitoring Technician
Pharmaceutical company in Lakewood NJ, is looking to hire Gown Qualified Operators. This position is Monday through Friday, open on multiple shift and provides full benefits.
Operate filling equipment in a controlled or non-controlled area to fill and seal product into containers as specified by batch record, and in accordance with all operational SOPs and cGMP requirements.
The Gown Qualified Operator is responsible for the full spectrum of duties in assigned filing room. This may include but is not limited to: set-up of room and equipment for production, operate equipment to meet product specifications and batch record requirements, ensures correct components and product according to production schedule and batch record, equipment and room cleaning and sanitization, etc
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Perform job function in strict accordance to room classification. When required consistently work using good aseptic technique and practices to ensure product quality.
- Operate all of the line equipment, typically filling equipment in controlled and non-controlled areas, cleaning and sanitization of controlled areas, preparation of components, as defined in applicable SOPs, work instructions and the product specific batch record.
- Perform all required manufacturing steps (i.e., fill weight checks, product sampling, etc.) as required by SOPs and product specific Batch records
- Clean and sanitize the operating equipment, supporting equipment and work areas and ensure that all equipment and the manufacturing areas are kept clean and sanitary during the course of normal operations, at the end of the shift, and as assigned otherwise. Document cleaning and sanitization as required.
- Document all operations and ensure that all documentation is completed according to required cGMPs and SOPs
- Monitor product during production , troubleshoot and make required adjustments to equipment to ensure that product attributes such as fill weights, cap torque and placement of components are acceptable
- Report any product quality issues to the Production Supervisor and Quality Supervisor.
- Ensure that safe work practices are employed in the performance of daily activities, Address and report any observations of unsafe behavior or practices immediately and any recommendations for safety improvements to the Manufacturing Coordinator and/or Supervisor.
- Ensure that in the performance of daily activities, all applicable cGMPs are employed. Immediately address and report to the Manufacturing Coordinator, Quality Assurance or the Production Supervisor any behavior or practice that is not cGMP compliant.
- Share operational knowledge with peers, new-hires, contingency staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance.
- Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business.
- Perform any other task that may be assigned by the Manufacturing Coordinator or Production Supervisor.
Pay: $21.00 - $25.00/hour based on expereince
- Supplemental medical coverage
- Prescription program
- Dental coverage
- Vision coverage
- Term life Insurance plan
- 2+ years experience working in Aseptic Environment (pharmacuetical, med device)
• Class A clean room experience preferred