Non-Aseptic Production Operator

TITLE:

Title: Non-Aseptic Production Operator

Reports To: Supervisor, Production

Location: Raleigh

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 the chronic conditions and co-occurring disorders of OUD. Indivior is 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 over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. 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 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 regards 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, 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.
• Assists in ensuring that schedule efficiency, product quality, regulatory, safety and financial goals are met.
• Maintains attendance requirements.
• Maintain proper hygiene as required by cGMPs.  

• Participate on working teams, as applicable.
• Assists departments and performs other duties as specified by the Production Supervisor.

• Ensure processes and products are in compliance with all local, state, and federal rules and regulations.   Oversee that processes are in cGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMPs, FDA, OSHA and other regulatory agencies.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent.
• Minimum five (5) years of related work experience in a regulated environment.
• Knowledge of cGMPs and ability to apply analytical reasoning and root cause analysis to solve problems.
• Gowning experience in a classified area is required.
• Excellent math/science skills and ability to use a computer.
• Demonstrated ability to read, understand, interpret, and apply technical writing and instruction.
• Strong communication skills:  both verbal and written.
• Focused attention to detail.
• Experience with batch records review, auditing, and a broad understanding of pharmaceutical production.
• Strong mechanical aptitude and root cause analysis, preferred.

COMPETENCIES/CONDUCT:

• Position requires continuous standing and walking. 
• Frequent bending over and lifting and carrying up to 50 lbs. Must be able to maintain gowning qualification as described in Standard Operating Procedures, and wear appropriate PPE as required. 
• Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products.
• All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.