Operations Technician - near Southglenn, CO

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Job Description

Position Summary:

Operations Technician will be responsible for routine and corrective cleaning of cleanroom equipment and performing operations in an ISO5 to ISO9 environment to produce drug product following approved Standard Operating Procedures (SOPs) related to these activities. Gowning and Personnel Protective Equipment (PPE) are required to perform job functions.  Position will also have some additional responsibilities in the general areas of facilities and maintenance, warehousing, inventory management, and contractor management.

Key Activities:

  • Maintain cleanliness of cleanroom equipment and associated areas.
  • Daily monitoring and checking of equipment/systems.
  • Perform minor preventative maintenance tasks.
  • Coordination of routine and non-routine contractors.
  • Monitors/tracks inventory and adjusts paperwork as needed.
  • Assists Operations and QA in the receipt, approval and release of materials.
  • Monitors and completes documentation for actions performed per cGMP.
  • Obtain and stock all consumable supplies related to cleaning. This includes cleaning solutions, cleaning supplies and gowning supplies following facilities flows.
  • Manage supplies and inform purchasing on re-ordering of materials.
  • Ability to read and perform approved Standard Operating Procedures (SOPs).
  • Ability to don gowning in an aseptic manner and maintain qualification throughout employment.
  • Assist Operations in the operation of processing equipment and executing production processes. Perform line clearance and batch preparation/reconciliation activities.
  • Perform daily activities in the processing area following all relevant SOPs.
  • Performs other duties as necessary.
Required Qualifications:
  • Excellent documentation and organizations skills required.
  • Ability to do basic math and conversions.
  • Ability to troubleshoot and identify problem areas within facility and offer solutions to remedy situations.
  • Requires the ability to learn GMP processes. Cleanroom experience is preferred.
  • Understands aseptic processing and compliance requirements. Previous knowledge of FDA, GMPs, OSHA Safety, SOPs and other regulations is preferred.

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Posted: Mar 23, 2018

Type: Full Time

Category: Operations Technicians Manufacturing GMP FDA