Non-Aseptic Operator I

Role Summary

The Non-Aseptic Production Operator I is responsible for operating processing and test equipment in environmentally controlled areas per Standard Operating Procedures. This includes roles such as Vial Inspectors, Component Prep, and Compounding/Formulation, and requires 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.
• Ensures equipment and work areas are cleaned and maintained; sanitize walls, ceilings, floors, countertops and tables; clear and clean production lines before and after operations.
• Reviews raw process data to ensure process standards are met; apply analytical reasoning and understanding of cGMP to assess compliance to cycle standards.
• Exercises sound judgment, attention to detail, and the ability to recognize and avert conditions that could affect equipment or product.
• Communicates with Production Management, Quality Assurance, Quality Control, Maintenance and Engineering regarding status of manufacturing operations, including equipment reliability, environmental problems, and potential quality concerns.
• Monitors manufacturing processes; verify and document production activities manually and on computerized systems (batch records, logbooks, etc.).
• Maintains a safe work environment and reports hazardous conditions to the supervisor.
• Setup and adjust equipment for proper operation, including disassembly/installation of equipment and parts; operate a variety of production equipment to support operations.
• Receive, check, store, handle and deliver bulk and finished drug products as required; use appropriate material handling equipment per safety policies.
• Follow established SOPs and documentation procedures; perform additional duties as assigned.

Qualifications

• Required: High School Diploma; Minimum one (1) year experience in a regulated environment or a BioWorks Certificate; gowning experience in a classified area; knowledge of cGMPs; basic math and science skills; ability to use a computer; ability to read, understand, interpret, and apply technical writing/instructions; strong verbal and written communication; attention to detail; experience with batch records and pharmaceutical production; mechanical aptitude preferred.
• Preferred: Ability to receive training, understand and execute instructions; signed off on at least 25% of OJT requirements for area within 6 months; understanding of Indivior Values & Behaviors.

Additional Requirements

• Physical requirements: continuous standing and walking; frequent bending, lifting up to 50 lbs; must wear appropriate PPE; health conditions that may affect safety/quality must be reported.