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Manufacturing Operator I - Derm - Windsor

Company: TOLMAR
Location: Windsor
Posted on: January 12, 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".
  • 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
    • Full Face-Respirator or PAPR (Powered Air Purifying Respirator)
    • Properly perform the Done By function on batch records in accordance to cGMP standards.
    • Assist in the set-up of semi-automatic filling equipment used to fill dermatological products.
    • Operate fast-paced, basic production equipment with manual loading processes.
    • Perform routine sampling and inspections for product attributes (fill weights, product sealing, labeling) of filled products.
    • Assist in the set-up of semi-automatic labeling equipment used to apply labeling to pre-filled jars, bottles and vials.
    • Perform biological sampling of general manufacturing cleanroom facilities.
    • Document production activities using regulatory controlled documents including production records and log books.
    • Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by Tolmar Standard Operating Procedures.
    • Responsible for assembly, disassembly and sanitation of various equipment.
    • Ensure that the quality of product being produced on assigned production line meets specified standards.
    • Operate under the direct supervision of a Lead Operator and/or 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).
      • Working knowledge of computer software.
      • Ability to maintain focus on detail-oriented, repetitive tasks.
      • Good verbal and written communication skills.
      • 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.
      • Attention to detail for documentation in production documents and to compare produced goods against specified requirements.
      • Capability to operate on a fast-paced manual assembly line using basic production equipment.
      • Ability to legibly complete required documentation.
      • Attention to detail for documentation in production documents and to compare produced goods against specified requirements. Core Values
        • The Manufacturing Operator I - Derms is expected to operate within the framework of Tolmar's Core Values:
          • Consistently operate with the highest standards of ethics and compliance.
          • Take ownership of your actions, success and setbacks.
          • Respect each other and understand that honest collaboration is at the heart of our company success.
          • Go the extra mile to make things happen.
          • Be committed to all we do and the patients we serve.
          • Embrace change with enthusiasm.
          • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task. Communication
            • Interact with peers and members of other departments in team settings in a professional manner. Education& Experience
              • High school diploma or equivalent required.
                • 1 or more years of experience in a GMP manufacturing environment. 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: 9:00 P.M. - 7:30 A.M. Monday - ThursdayEqual 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 Operator I - Derm - Windsor, Other , Windsor, Colorado

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