Core Hours will Vary, with Most Production Occurring Between 6am - 6pm
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
- Full-face masks/hoods
- Goggles
- Chemical Protection PPE
- Set up and operate 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.
- Set-up and operate of semi-automatic packaging equipment used to package pre-filled syringes.
- Property load pre-filled syringes and components into semi-automatic packaging equipment.
- Formulate bulk materials.
- Weigh, measure, and check raw materials to assure batches contain proper ingredients and quantities.
- Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures.
- Set up and operate bulking operations.
- Identify need for minor maintenance on aseptic production equipment and assist with set-up.
- Properly perform the Done By function on batch records in accordance with cGMP standards.
- Assist with equipment steam in place (SIP) on equipment used for sterile bulking processes.
- Ensure that product quality adheres to approved specifications.
- Assist and support any aseptic process development activities/projects as determined by Aseptic Development Operations Manager.
- Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
- 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.
- 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.
- Must be able to keep accurate records and able to perform mathematical calculations.
- Ability to legibly complete required documentation.
- Strong attention to detail required for documentation in production documents.
- Capability to operate on a fast-paced manual assembly line using basic production equipment.
- Ability to learn Aseptic technique and work in an aseptic environment.
- Ability to wear respirator for extended periods of time while working on tasks (up to 4 hours).
- Ability to lift up to 40 lbs.
- Ability to lift arms above shoulder height repetitively for duration of shift while cleaning.
Core Values
- The Manufacturing Operator I - Aseptic Development 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.
- One or more years of experience in an aseptic (sterile) manufacturing environment preferred.
- Two or more years of experience in a manufacturing role 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.
- Passing results on an internal inspection qualification for syringe inspection on semi-automated equipment for one syringe type.
Working Conditions
- Working conditions are normal for a Manufacturing Environment
Compensation and Benefits
- Pay: $23.33 per hour
- Benefits summary: https://www.tolmar.com/careers/employee-benefits
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.