Manufacturing Operator I - Aseptic (3rd Shift)

United States·Windsormid

OtherManufacturing Operator

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Quick Summary

Requirements Summary

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,

Technical Tools

OtherManufacturing Operator

Sunday - Wednesday, 5:00 pm - 5:30 am (every other Wednesday off)

The Manufacturing Operator I - Aseptic performs routine activities related to supporting the injectable team, while ensuring that products are made with quality for our patients.

Responsibilities

~2 min read

→Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time".
→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

→Assist in setup and manufacture (bulk, fill, stopper, label, and package) clinical supplies and commercial pharmaceutical products in an aseptic environment in accordance with production batch records.
→Assist in the set-up and operation of semi-automatic filling equipment used to fill syringes for injectable products in both general manufacturing and sterile manufacturing areas.
→Perform routine sampling and inspections of pre-filled syringes for injectable products.
→Assist in the set-up and operation of compounding equipment used to produce bulk material for injectable products.
→Perform biological sampling of general manufacturing clean room facilities.
→Assist in set-up and operation of semi-automatic packaging equipment used to package pre-filled syringes.
→Document production activities using regulatory controlled documents including production records and log books.
→Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by TOLMAR Standard Operating Procedures.
→Perform visual and physical inspections of in-process and finished product as requested.
→Responsible for assembly, disassembly and sanitation of various equipment.
→Perform job duties with a second checker present.
→Responsible for quality of product.
→Train other Aseptic Operators in the Injectable Products team to perform job duties related to their position.
→Handle hazardous raw materials and cleaning solutions following all applicable safety procedures and policies.
→Formulate bulk materials.
→Maintain proper use of aseptic techniques.
→Operate under the direct supervision of a Lead Operator and/or Supervisor.
→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.

Working knowledge of current Good Manufacturing Procedures (cGMP).
Ability to stand for extended periods of time (up to 8 hours or more).
Working knowledge of 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.
Strong math and writing skills to document production activities in batch records and/or log books.
Attention to detail for documentation in production documents and to compare produced goods against specified requirements.
Capability to operate on a fast-paced manual assembly line using basic production equipment.
Ability to legibly complete required documentation.

The Manufacturing Operator I - Aseptic 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.