Non-Aseptic Production Operator I

TITLE:

Non-Aseptic Production Operator I

Title: Non-Aseptic Production Operator I

Reports To: Supervisor, Non-Aseptic Production, Raleigh

Location: Raleigh, NC

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior. 

POSITION SUMMARY:

The Non-Aseptic Production Operator I position is working in the roles of Vial Inspectors, Component Prep, & Compounding/Formulation. This person would be responsible for the operation of various types of processing and test equipment in environmentally controlled areas per Standard Operating Procedures. This would include but is not limited to steam sterilizers, formulation tanks and associated equipment, analytical balances, pumps, filter test equipment and other associated equipment. As part of these responsibilities, the Production Operator I monitors cycles, and reviews data to ensure requirements have been met and completes all associated documentation.

The Non-Aseptic Production Operator levels are differentiated based on the ability to perform tasks in various areas independently and with a high level of proficiency and knowledge of the area and equipment. Operator I level associates will be expected to meet these minimum requirements:

• Ability to receive training, understand what is taught and execute as instructed.

• Signed off on at least 25% of the OJT requirements for your area of focus within 6 months.

• Understand the Indivior Values & Behaviors.

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:

· 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 syst