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Apex Life Sciences

Manufacturing Technician I - GMP, sterile experience

Post Date:Nov 14, 2017Type:Contractor
Start Date:11/14/2017Salary:
Location:US-NJ-Ridgefield Job Reference:800412
Skills:
 

Job Description:

Duties:

  • Perform tasks of the production operation specific to bulk formulaton and aseptic filling line support.
  • Serve as witness of routine unit operation tasks for batch record signing.
  • Maintains all associated documentation for operations being performed.
  • Maintains batch record documentation and logs as required by corporation and regulatory agencies.
  • Performs cleaning and sanitizing of production equipment and classified production space.
  • Prepares, according to procedures, various stock solutions and buffers as required by the production process.
  • Prepares equipment, glassware, filters, etc. required for production.
  • Assists in process and system validation activities as required. Independently performs product sampling, environmental monitoring, or other related activities as directed.
  • Independently performs routine tasks in the areas of Aseptic Syringe Filling such as Operation of the syringe filling while monitoring critical parameters as per procedures. 

Skills:

  • Associate's degree in related discipline required; Bachelor's degree preferred
  • 1+ year's experience working in GMP environment is preferred.
  • Experience with revision and review of SOPs and BPRs is preferred.
  • Prior mechanical experience and experience working as an Aseptic Production operator is preferred.
  • Knowledge of FMEAs, RAs, CAPAs, CCRs, NCRs, and Action Items a plus.
  • Demonstrated ability to apply experience to perform equipment troubleshooting, monitor employee activities and to make procedural revisions, as needed.
  • Implements and maintains production schedules based upon intra-departmental information.
  • Ability to ensure compliance with GMPs and SOPs.
  • Takes initiative to identify issues and keep leads and management informed.




Contact Information
Apex Life Sciences



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