Manufacturing Production Associate Rochester United States,
UNITHER Pharmaceuticals (company)
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The Production Associate is responsible for manufacturing or packaging pharmaceutical components and products by setting-up, cleaning, operating, and maintaining equipment. Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply. The Production Associate is expected to fully participate in both departmental projects and any quality working teams that may be applicable. This position shall be responsible for the hands on execution of activities as they relate to the manufacturing or packaging of products. Supports the leader and subject matter (SME) expert in their area(s) of responsibility. Supports production, operations projects and process improvements. Maintains accurate and compliant documentation on all activities.
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- Knowledge of manufacturing processes and demonstrated leadership capabilities are preferred.
- General understanding of material handling machinery is advantageous.
- Demonstrate basic math skills in multiplication, division, percentage calculation, significant figures, conversion from metric to standard measures (or inverse), and weight to volume measures (or inverse). This would include basic algebra and geometry.
- Must understand and abide by the requirements for working in a regulated industry. These include cGMPs, DEA regulations, and HS&E requirements.
- Basic mechanical knowledge and aptitude.
- Ability to learn the operation and function of multiple pieces of equipment.
- Use of basic hand tools such as wrenches, screwdrivers, measuring devices.
- Knowledge of computer applications and current software is desirable.
- Must be able to lift up to 50 pounds
- Must have physical mobility and dexterity to frequently stand, bend, push, twist, kneel, climb, stoop, and reach overhead
- Considerable mental/visual concentration, coordinating manual dexterity with mental/visual attention.
- Mental/visual attention plus manual coordination.
- Routinely drives/operates lifts
- Works with chemicals, tools, and equipment
- May work in an environment with variable but moderately high noise levels (hearing protection recommended). Must wear safety glasses, safety shoes, gloves, and other protective items as required.
- Must wear appropriate garments and coverings per cGMP (uniforms, hair/beard nets, etc.).
- Must be available for flexible schedule and/or overtime. Days and hours of work subject to change due to production schedules.
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