Randstad Aseptic Production Operator (Friday, Saturday, Sunday 7am-7pm) in Raleigh, North Carolina

Aseptic Production Operator (Friday, Saturday, Sunday 7am-7pm)


Raleigh, NC


US$ 16 - US$ 20 per hour

Date Posted:

Monday, October 10, 2016

Job Type:


Reference #:






Randstad USA Manufacturing & Logistics


The Aseptic Production Operator I position is responsible for the operation of various types of processing and test equipment in aseptic areas, using excellent aseptic practices and behaviors, per Standard Operating Procedures. This includes but is not limited to: steam sterilizers, filling equipment, performing interventions, transfer carts, and capping equipment and other associated equipment.

- Comply 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.-

- 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.

- 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.

Working hours: 40+


--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.

--Exercise sound judgment, meticulous attention to detail, and the ability to recognize and avert situations that could adversely affect equipment and/or product.

--Demonstrated ability to read, understand, interpret and apply technical writing and instruction.

--Communication skills:- both verbal and written.

--Accurate attention to detail, experience with batch records review, auditing, and a broad understanding of pharmaceutical production.

--Mechanical aptitude and root cause analysis, preferred.

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