Manufacturing Operator I - Paliperidone (2nd Shift)

TOLMAR Inc. • Windsor, CO • 10h ago

Core Hours: Monday - Friday 2:00pm - 10:30pm

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 - Pali 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.

Communication Interact with peers and members of other departments in team settings in a professional manner.

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