Description

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

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.
• 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

Qualifications

Education

High School (required)

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

The 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)

Last updated : 2024-03-24