Non-Aseptic Production Operator I

Role Summary

Non-Aseptic Production Operator I position working in roles of Vial Inspectors, Component Prep, and Compounding/Formulation. Responsible for operating various processing and test equipment in environmentally controlled areas per SOPs, monitoring cycles, reviewing data to ensure requirements are met, and completing associated documentation.

Responsibilities

• Complies with cGMP through adherence to SOPs, Master Batch Record Instructions, and company policies with a focus on quality and safety to produce parenteral products that improve public health. Ensure training is in compliance with the job role/tasks before performing any activities in the production operation.
• Ensures equipment is cleaned and maintained properly, and work areas are clean, including sanitization of walls, ceilings, floors, countertops and tables. Clear and clean production lines before and after all operations.
• Review raw process data to ensure process standards are met. Apply analytical reasoning and understanding of cGMP production to assess compliance to cycle standards.
• Exercise sound judgment, attention to detail, and the ability to recognize and avert situations that could affect equipment and/or product.
• Communicate with Production Management, Quality Assurance, Quality Control, Maintenance and Engineering staff regarding status of manufacturing operations, including equipment reliability, environmental problems, and potential quality and compliance concerns.
• Monitor manufacturing processes. Verify and document production activities manually and on computerized systems, including batch records and logbooks, to ensure production requirements are met.
• Maintain a safe work environment and report hazardous conditions to the supervisor.
• Set up and adjust equipment for proper operation, including disassembly and installation of equipment and parts required for production operations. Operate a variety of production equipment to support production operations.
• Receive, check, store, handle and deliver bulk and finished drug products as required or directed. Use appropriate material handling equipment following safety policies.

Qualifications

• High School Diploma required
• Minimum one (1) year experience in a regulated environment or a BioWorks Certificate required
• Gowning experience in a classified area required
• Knowledge of cGMPs
• Basic math and science skills and ability to use a computer
• Ability to read, understand, interpret, and apply technical writing and instruction
• Strong verbal and written communication skills
• Attention to detail
• Experience with batch records handling and broad understanding of pharmaceutical production
• Mechanical aptitude preferred

Skills

• Analytical reasoning
• Attention to detail
• Effective communication
• Problem-solving and decision-making
• Team collaboration

Education

• High School Diploma or equivalent

Additional Requirements

• Position requires continuous standing and walking. Frequent bending and lifting up to 50 lbs. Must wear appropriate PPE as required. Exclude if health condition could affect safety/quality of drug products until corrected.