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Km80.5

Aseptic Production Operator I (Temp 3-6 months)

Fresenius Kabi USA, LLC

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Location: Raleigh, NC Posted Date: 5/23/2013 Position Type: Contract Job Code: PMO Required Education: High school or equivalent Areas of Expertise Desired: Communications
Environmental Health & Safety
Manufacturing/Production
Other
Production Planning
Quality Control

Description

POSITION SUMMARY

The Aseptic Production Operator I 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, vial capper, tray loader, filler, lyophilizer and filter tester. As part of these responsibilities, the Aseptic Production Operator I monitors cycles and reviews data to ensure requirements have been met and completes all associated documentation. The Aseptic Production Operator I ensures that the equipment is cleaned and maintained properly and the work areas are clean and maintained as required. This requires in some cases sanitization of walls, ceilings and floors as well as counter tops and tables.
The Aseptic Production Operator I is responsible for reviewing raw cycle data to ensue process standards are met. Analytic reasoning ability and an understanding of the principles of aseptic production as required to accurately assessing compliance to cycle standards.  
Cost associated with production equipment and products are extremely high. The Aseptic Production Operator I must exercise sound judgment, meticulous attention to detail, and the ability to recognize and avert situations that could adversely affect equipment and/or product. The Aseptic Production Operator I must have good communication and team building skills.
The Aseptic Production Operator I is responsible for maintaining a safe work environment and reporting any potentially hazardous conditions to supervisor.

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

1.  Ensure that the work area and production equipment is cleaned and
   well maintained following each operation. Perform specified minor
   preventive maintenance as instructed.
2.  Setup and adjust equipment as required for proper operation,
   including disassembly and installation of all equipment and parts
   required for product runs. Operates various production equipment:
   steam sterilizers, vial/parts washers, compounding equipment,
   depyrogenation tunnel, vial capper, tray loader, filler, lyophilizer
   and filler tester. 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.
3.  Assists in ensuring that schedule efficiency, regulatory, safety and
   financial goals are met.
4.  Meet attendance requirements for the job.
5.  Maintain proper hygiene as required by cGMP’s.  
6.  Communicates with Quality Operations Management and Engineering staff
   pertaining to status of manufacturing operations, including but not
   limited to: process investigations, deviations, reconciliation and
   rejections; assist with the training of other employees as directed;
   participate on working teams; clear and clean production lines as
   required before and after all operations. On occasions, provide short
   presentations on team accomplishments.
7.  Monitors manufacturing cycles. Verify document production activities
   both manually and on computer systems, including batch records, log
   books, etc. to ensure requirements of production have been met.
8.  Obtain and maintain aseptic gowning qualification.
9.  Other duties as specified by the Production Supervisor.
10. Assists other departments and shifts as needed.
11. Comply with cGMP through adherence to SOP’s, Master Batch Record
   Instructions, and company policies relating to quality, safety,
   housekeeping and cost effectiveness.

Requirements

1.  Knowledge of cGMP’s
2.  Ability to apply analytical reasoning and root cause analysis to
   solve problems.
3.  Basic math and science skills and ability to use a computer.
4.  Demonstrated ability to read, understand, interpret and apply
   technical writing and instruction.
5.  Strong communication skills:  both verbal and written.
6.  Accurate attention to detail, experience with batch records review,
   auditing, and a broad understanding of pharmaceutical production.
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