Purpose and Scope

The Lead Operator performs routine activities related to supporting the injectable team, while ensuring products are made with quality for our patients.

Essential Duties & Responsibilities

• Perform job in a clean room environment requiring clean room gowning
• Perform setup/operations/disassembly/trouble-shooting of labeling equipment used to pre-filled syringes and/or vials, including equipment in the sterile support areas.
• Perform setup/operation/disassembly/trouble-shooting of semi-automated packaging equipment used to package pre-filled syringes.
• Perform setup/operations/disassembly/cleaning/trouble-shooting of syringe filler.
• Perform in-process sampling, testing and inspection on the packaging line.
• Ensure that product quality adheres to approved specifications.
• Perform syringe inspections using SIE (Syringe Inspection Equipment).
• Perform setup data acquisition program for in-process testing for syringe filling.
• Operate data acquisition program for in-process testing for syringe filling.
• Perform setup/execution/disassembly for small bulk processing.
• Stage production lots for processing.
• Perform line clearance and 1^st article approval.
• Perform batch record review.
• Perform setup/execution/cleanup of needle cleaning process.
• Perform cleaning and environmental monitoring of process rooms.
• Provide supervision to team members in the absence of a supervisor. 
• Order Supplies.
• Ensure that employees in assigned process follow safe work practices.
• Perform job responsibilities in accordance with standard operation procedures (SOPs) and production records with an expectation of “Right the First Time.”
• Train Operators and Technicians in the Injectable Products team to perform job duties related to their position.
• 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

• Working 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.
• Attention to detail is required for documentation in production documents.
• 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 - Injectables 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.
• Acceptable results on basic skill assessment.

Working Conditions

• Shift work in a manufacturing
• May require overtime

Compensation and Benefits

• Pay: $30.16 per hour
• Shift differential: $1.50 per hour 
• Benefits summary: https://www.tolmar.com/careers/employee-benefits