DescriptionPurpose and ScopeThe Lead Operator performs routine activities related to supporting theinjectable team, while ensuring products are made with quality for ourpatients.

Essential Duties & ResponsibilitiesPerform job in a clean room environment requiring clean room gowningPerform setup/operations/disassembly/trouble-shooting of labelingequipment used to pre-filled syringes and/or vials, including equipment inthe sterile support areas.

Perform setup/operation/disassembly/trouble-shooting of semi-automatedpackaging equipment used to package pre-filled syringes.

Perform setup/operations/disassembly/cleaning/trouble-shooting ofsyringe 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 syringefilling.

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 1st 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 jobduties related to their position.

Identify and support the implementation of continuous improvement and OEEinitiatives.

Participate in required annual hazardous waste training. Hazardous wasteinvolvement may include, but is not limited to container and tank managementand inspections, generation of hazardous waste as a part of production orsampling processes and transfer of hazardous waste between lab procedurearea, satellite accumulation and storage. Respond to spills per the ChemicalSpill Procedures.

Perform other duties as assigned.

Knowledge, Skills & AbilitiesWorking knowledge of current Good Manufacturing Procedures (cGMP).Interact with peers and members of other departments in team settings in aprofessional manner.

Provide clear and consistent communication when interacting with team membersand management.

Ability to lead by example and have a proven record of excellence inattendance, dependability and safety.

Provide necessary coaching, guidance and mentorship to operators andtechnicians 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 documentproduction 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 basicproduction 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 ValuesThis position is expected to operate within the framework of

Tolmar's CoreValues:

Center on

People:

We commit to support the well-being of our patients. Weare committed to treating our employees and those we serve as valued partners.

By placing people at the heart of our actions, we actively engage,invigorate, acquire knowledge, and grow together.

Are Proactive & Agile:

We embody a culture of engagement and action. Witha hands-on approach, we fearless y adapt to change. We anticipate, respondswiftly and efficiently to ignite a spirit that propels us towardsextraordinary outcomes.

Act Ethically:

We are committed to consistently conducting our business inan ethical, compliant, and socially aware manner, in line with ourpurpose of positively impacting lives. We actively cultivate diversity,equity, inclusion & sustainability in our workplace.

Constantly Improve:

We are committed to a collaborative & proactive effortto improve our products, systems, processes, and services by reducingwaste, increasing efficiency & improving quality.

Are Accountable:

We think, act, and communicate with honesty,transparency, and clarity in alignment with our core values. We don'tcompromise our values for near term gain. We take accountability & ownershipof our work, actions, successes, and setbacks. We strive to deliver ourbest as we shape the future.

RequirementsHigh school diploma or GED required.3 or more years of experience in a GMP manufacturing environment.

Acceptable results on basic skill assessment.

Working ConditionsShift work in a manufacturingMay require overtime

Compensation and BenefitsPay:

$31.28 per hourShift differential: $1.50 per hourBenefits summary: https://www.tolmar.com/careers/employee-benefits