TITLE:

Non-Aseptic Production Operator I

Title: Non-Aseptic Production Operator I

Reports To: Supervisor, Non-Aseptic Production, Raleigh

Location: Raleigh, NC

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 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.

General Duties

· Follow established SOPs and documentation procedures

· Perform additional duties and responsibilities as assigned

MINIMUM 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.

Physical Requirements of the Role

Position requires continuous standing and walking. Frequent bending over and lifting and carrying up to 50 lbs. Must 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.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

· Embrace Indivior core culture principles

· Embrace the dynamics of team support, team collaboration and team success

· Celebrate the core wins of the organization and empower others to sustain a quality mindset

· Always have patient safety at the forefront in the efforts to provide safe and effective products to enhance and improve lives

· Celebrate and embrace diversity, equity, and inclusion