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Manufacturing Technician I - Aseptic

Company: TOLMAR
Location: Fort Collins
Posted on: January 11, 2019

Job Description:

Key Responsibilities

  • Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of"Right the First Time".
  • Record data in notebooks or lab forms and accurately calculate results to support process.
  • Perform job in a clean room environment requiring clean room gowning, including but not limited to:
    • Company-provided Scrubs
    • Shoe Covers and Sterile boot covers
    • Hairnets (and beard covers as applicable)
    • Tyvek Coveralls
    • Gloves
    • Face mask
    • Goggles
    • Chemical Protection PPE
    • Assist in the set up and operation labeling equipment used to label pre-filled syringes and/or vials, including equipment in the sterile support areas.
    • Properly load pre-filled syringes and/or vials into labeling equipment.
    • Assist in the set up and operation of semi-automatic packaging equipment used to package pre-filled syringes.
    • Properly load pre-filled syringes and components into semi-automatic packaging equipment.
    • Accurately document production activities using regulatory controlled documents including production records and log books.
    • Properly perform the Done By function on batch records in accordance to cGMP standards.
    • Identify need for minor maintenance on aseptic production equipment and assist with set-up.
    • Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
    • Maintain proper use of aseptic techniques.
    • Perform facility cleaning of critical aseptic environment as required to maintain a cGMP environment and in accordance with Standard Operating Procedures.
    • Ensure that product quality adheres to approved specifications.
    • Operate under the direct supervision of a Lead Operator and/or Aseptic Supervisor.
    • Perform other duties as assigned. Special Skills and Knowledge
      • Working knowledge of current Good Manufacturing Procedures (cGMP).
      • Ability to stand for extended periods of time (up to 8 hours or more).
      • Understanding of basic computer software.
      • Ability to maintain focus on detail-oriented, repetitive tasks.
      • Ability to follow and understand written production records and validation protocols.
      • Understanding of basic math and writing skills to document production activities in batch records and/or log books.
      • Must be able to keep accurate records and able to perform mathematical calculations.
      • Ability to legibly complete required documentation.
      • Attention to detail is required for documentation in production documents.
      • Ability to be respirator-qualified and wear respirator for extended periods of time (up to 4 hours) while performing cleaning of area.
      • Capability to operate on a fast-paced manual assembly line using basic production equipment.
      • Ability to manually assemble components.
      • Ability to lift up to 40 lbs.
      • Ability to lift arms above shoulder height repetitively for duration of shift during periods of area cleaning. Communication
        • Interact with peers and members of other departments in team settings in a professional manner. Education& Experience
          • High school diploma or equivalent required.
            • Experience in a manufacturing environment preferred but not required. Additional Requirements
              • Acceptable results on both a quantitative and verbal assessment test.
              • Valid driver's license and acceptable motor vehicle record may be required.
              • Shift work in a manufacturing and warehouse environment.
              • May require overtime.Core hours are Saturday through Tuesday 6:00am - 4:30pm.
                Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

                Keywords: TOLMAR, Denver , Manufacturing Technician I - Aseptic, Engineering , Fort Collins, Colorado

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