Non-Aseptic Production Operator

TITLE:

Non-Aseptic Production Operator

Title: Non-Aseptic Production Operator

Reports To: Associate Director of Production

Location: Raleigh

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD 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.

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time.  Our purpose is to bring science-based, life-transforming treatments to patients.  We strive to help eliminate the stigma of addiction.  We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.

We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation.  We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.

Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

POSITION SUMMARY:

The Non-Aseptic Production Operator position is working in the roles of Syringe Inspector, Parts Washer, Component Prep, & Compounding/Formulation. They are responsible for the operation of various types of processing and testing equipment in environmentally controlled areas per Standard Operating Procedures. This includes but is not limited to manual visual inspection booths, steam sterilizer(s), parts washer(s), pouching equipment, formulation tanks, and associated equipment, weight scales, pumps, filter testing equipment and other associated equipment. As part of these responsibilities, the Production Operator monitors cycles, and reviews data to ensure requirements have been met and completes all associated documentation.

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 III levels will be expected to be a lead in their respective areas and have additional responsibilities beyond operation of the equipment including:

• Being an On-the-Job Trainer (OJT) for less senior associates.
• Signed off on 100% of on three of the OJT requirements for your areas of focus.
• Being a Subject Matter Expert (SME) in your areas of focus.
• Being a Single Point of Contact (SPOC) for other support areas for issues needing resolution.
• Leading by example with regard to Indivior Values & Behaviours.

ESSENTIAL FUNCTIONS:

The responsibilities of this role 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, inc