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Manufacturing Technician I - Aseptic (2nd Shift, Wed - Sat)
at TOLMAR Inc.
- 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
- Face mask
- 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.
- The Manufacturing Technician I - Aseptic 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.
- 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.
- 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: Wednesday - Saturday 3:00 p.m. - 1:30 a.m.
$15.18/hour plus $1 shift differential