Non-Aseptic Production Operator I

Role Summary

Non-Aseptic Production Operator I

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 the public health. Ensure training is in compliance with the job role/tasks before performing any activities in the production operation.
• Ensures that the equipment is cleaned and maintained properly, and the work areas are clean and maintained as required. This requires sanitization of walls, ceilings and floors as well as counter tops and tables. Clear and clean production lines as required before and after all operations.
• Responsible for reviewing raw process data to ensure process standards are met. Analytical reasoning ability and an understanding of the principles of cGMP production are required to accurately assess compliance to cycle standards.
• Exercises sound judgment, meticulous attention to detail, and the ability to recognize and avert situations that could adversely affect equipment and/or product.
• Communicates with Production Management, Quality Assurance, Quality Control, Maintenance and Engineering staff pertaining to status of manufacturing operations, including but not limited to: equipment reliability, environmental problems, and potential quality and compliance concerns.
• Monitors manufacturing processes. Verify and document production activities both manually and on computerized systems, including batch records, logbooks, etc. to ensure requirements of production have been met.
• Responsible for maintaining a safe work environment and reporting any potentially hazardous conditions to supervisor.
• Setup and adjust equipment as required for proper operation, including disassembly and installation of all equipment and parts required for production operations. Operate a variety of production equipment, as mentioned above, to support production operations.
• Receive, check, store, handle and deliver bulk and finished drug products as required or directed. Utilize appropriate material handling equipment in accordance with standard operating 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 is required.
• Knowledge of cGMPs.
• Basic math and science skills and the ability to use a computer.
• Demonstrated ability to read, understand, interpret, and apply technical writing and instruction.
• Strong communication skills: both verbal and written.
• Attention to detail.
• Experience with batch records handling, and a broad understanding of pharmaceutical production.
• Mechanical aptitude preferred.

Skills

• cGMP compliance
• Documentation and data review
• Equipment operation and maintenance
• Analytical reasoning
• Communication with cross-functional teams

Education

• High School Diploma or equivalent; related certifications considered

Additional Requirements

• Physical requirements: Position requires continuous standing and walking. Frequent bending over and lifting and carrying up to 50 lbs. Must wear appropriate PPE as required.