Manufacturing Lead Operator

• Injectable (Monday
• Friday 2:00pm
• 10:30pm Tolmar Inc.
• 2.

9 Fort Collins, CO Job Details Full-time $31.28 an hour 8 hours ago Qualifications CGMP Writing skills Basic math GMP Mid-level 3 years High school diploma or GED Agile Manufacturing Full Job 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 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 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 This position is expected to operate within the framework of

Tolmar's Core Values:

Center on

People:

We commit to support the well-being of our patients. We are 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. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.

Act Ethically:

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

Constantly Improve:

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

Are Accountable:

We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future. 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:

$31.28 per hour Shift differential: $1.50 per hour Benefits summary: https://www.tolmar.com/careers/employee-benefits Education Required High School or better Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.