Manufacturing Lead Operator

4 weeks ago

Windsor CO United States Tolmar Full time
DescriptionCore Hours
Monday - Friday, 6:00 am - 2:30 pm
Purpose and Scope
The Lead Operator supervises and leads processes related to the inspection and packaging of Tolmar products, while ensuring products are made with quality for our patients.
Essential Duties & Responsibilities

  • Perform job responsibilities in accordance with standard operation 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
    • Hairnets (and beard covers as applicable)
    • Tyvek Coveralls
    • Gloves
    • Face mask

    • Set-up and operate semi-automatic packaging equipment used to package pre-filled syringes. Automated packaging equipment includes (but not limited to): Semi-Automated inspection, Thermoformer, Syringe connecting, Labeler/Vision systems, Cartoning & Serialization.
    • Troubleshoot automated equipment in parallel with Maintenance/Engineering.
    • Perform in-process sampling, testing and inspection on the packaging line.
    • Ensure that product quality adheres to approved specifications.
    • Perform setup data acquisition program for in-process testing for syringe filling.
    • Operate data acquisition program for in-process testing for syringe filling.
    • Stage production lots for processing.
    • Perform line clearance and 1st article approval.
    • Perform batch record review.
    • Perform cleaning and environmental monitoring of process rooms.
    • Order Supplies.
    • Ensure that employees in assigned process follow safe work practices.
    • Train Operators and Technicians on the packaging team to perform duties related to their position.
    • Qualify and maintain 100% inspections of pre-filled syringes.
    • Identify and support the implementation of continuous improvement and OEE initiatives.
    • Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
    • Perform other duties as assigned.

      Knowledge, Skills & Abilities

      • Mastered knowledge of current Good Manufacturing Procedures (cGMP).
      • Interact with peers and members of other departments in team settings in a professional manner.
      • Provide clear and consistent communication when interacting with team members and management.
      • Ability to lead by example and have a proven record of excellence in attendance, dependability and safety.
      • Provide necessary coaching, guidance and mentorship to operators and technicians related to improvements of job performance.
      • Understanding of basic computer software.
      • Ability to follow and understand production records and procedures.
      • Understanding of basic math and writing skills to accurately document production activities in batch records and/or log books.
      • Strong 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 manually assemble components.
      • Ability to stand for extended periods of time (up to 8 hours).
      • Ability to lift up to 40 lbs.
      • Ability to perform activities above your head.
      • Successfully qualification of internal syringe visual inspection program.

        Core Values

        • The Lead Operator - Packaging 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.

              Requirements

              • High school diploma or GED required.
              • 3 or more years of experience in a GMP manufacturing environment.
              • 2 or more years of experience working with automated complex packaging equipment.

                Working Conditions

                • Shift work in a manufacturing
                • May require overtime

                  Compensation and Benefits

                  • Pay: $30.37 per hour, depending on experience
                  • Benefits summary:

                    Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
                    Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

                    Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe 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. 41 CFR 60-1.35(c)

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