The Aseptic Production Operator I position is responsible for operating various types of processing and test equipment in aseptic areas, using excellent aseptic practices and behaviors, per Standard Operating Procedures.
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.
- Complies with cGMP through adherence to SOP’s, 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 maintains compliance with the job role 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.
- Responsible for reviewing raw cycle data to ensure process standards are met.
- 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 & compliance concerns.
- Monitors manufacturing cycles. Verify and document production activities both manually and on computer 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 or safety incidents immediately to your supervisor.
- Cleaning, Setup, and adjustments of equipment as required for proper operation, including disassembly and installation of all equipment and parts required for product runs.
- 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.
Benefits
- Competitive PTO
- Company closure from December 24th- January 1st
- 401(k) and Profit-Sharing Plan- Company match
- U.S. Employee Stock Purchase Plan- 15% Discount
- Comprehensive Medical, Dental, Vision, Life and Disability coverage
- Health, Dependent Care and Limited Purpose Flex Spending and HSA options
- Adoption assistance
- Tuition reimbursement
- Concierge/personal assistance services
- Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
- Wellness programs as well as other discounts and perks
