Job Description
The Production Operator I position is responsible for the operation of various types of processing and test equipment in environmentally controlled areas per Standard Operating Procedures. This includes but is not limited to: steam sterilizers, vial/parts washers, depyrogenation tunnel, 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.
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.
**First Shift (Monday-Thursday 7AM - 7PM EST each day)
KEY RESPONSIBILITIES
- 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 is in compliance with 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. 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 cycle 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 cycles. Verify and document production activities both manually and on computer systems, including batch records, log books, 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 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.
- Assists in ensuring that schedule efficiency, product quality, regulatory, safety and financial goals are met.
- Meet attendance requirements for the job.
- Maintain proper hygiene as required by cGMP’s.
- 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.
REQUIREMENTS
- High school diploma or equivalent
- 1-3 years of relevant experience
- Knowledge of cGMP’s and ability to apply analytical reasoning and root cause analysis to solve problems.
- Basic math and 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.
- Attention to detail.
- Related work experience in a regulated environment, preferred.
- Strong mechanical aptitude and root cause analysis, 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.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.