Operator I, Non-Aseptic Production
- Posted: over a month ago
Sagent Pharmaceuticals - Raleigh, North Carolina
Production Operator- Non-Aseptic Production
The Production Operator 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: Vial Inspectors, Vial Washers, Component Prep, Compounder, Lyophilization Technicians, Filling & Capping as well as Packaging Operators.
- Complies with cGMP through adherence to SOP’s, Master Batch Record Instructions, and company policies
- Ensure training is in compliance with job role before performing any activities in the production operation
- Ensure equipment is cleaned and maintained properly, and the work areas are clean and maintained
- 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
- 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.
- Meet attendance requirements for the job, maintain proper hygiene as required by cGMPs and 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.
All Sagent Candidate Requirements:
- High school diploma or equivalent
- 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
- Ability to stand, walk, bend and lift up to 50pds; must wear appropriate PPE and maintain gowning qualification, and physical requirements of the position.
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.
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.
Sagent Pharmaceuticals is an EEO/AA employer and does not discriminate on the basis of race, color, religion, sex, age, creed, national origin, veteran status, physical or mental disability and sexual orientation.
ManufacturingView all jobs at Sagent Pharmaceuticals