TOLMAR Inc.

Receive alerts when this company posts new jobs.

Similar Jobs

Job Details

Manufacturing Technician I - Aseptic (2nd Shift, Wed - Sat)

at TOLMAR Inc.

Posted: 10/21/2019
Job Status: Full Time
Job Reference #: c1cf2169-9d4b-435e-9705-1bf88829cd5d
Keywords: company

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.

 

Core Values

  • 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.

 

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: Wednesday - Saturday 3:00 p.m. - 1:30 a.m. 

$15.18/hour plus $1 shift differential