Purpose and Scope
The Packaging Assembler provides general support for the manufacturing department with a focus on injectable products, while ensuring that our products are made with quality for our patients.
Essential Duties & Responsibilities
- Perform job in a clean room environment requiring appropriate gowning in each area.
- Assist in the set up and operation labeling equipment used to label pre-filled syringes and/or vials, including equipment in the sterile support areas.
- Assist in the set up and operation of semi-automatic packaging equipment used to package pre-filled syringes.
- Perform in-process sampling, testing and inspection on the packaging line.
- Assist for cleaning and environmental monitoring of process rooms.
- Perform setup/execution/cleanup of needle cleaning process.
- Ensure that product quality adheres to approved specifications.
- Perform job responsibilities in accordance with standard operation procedures (SOPs) and production records with an expectation of “Right the First Time.”
- 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.
- Understanding of basic computer software.
- Ability to follow and understand production records and procedures.
- Understanding 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.
Core Values
This position is expected to operate within the framework of The following Core Values:
- Center on People: We commit to support the well‑being of our patients and treat 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 with an enterprise‑wide mindset that lifts the whole organization.
- 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 proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk‑taking that drives better ways of working.
- 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.
- Experience in a manufacturing environment preferred but not required.
Working Conditions
- Shift work in a manufacturing area
- May require overtime
