Filling Operator I (11pm-7:30am)

Nature and Scope

This entry level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management, the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting company goals.

Essential Duties And Responsibilities

• Performs duties required in the washer/capper area to established standards of productivity and quality as per standard operating procedures.
• Adheres to good manufacturing practices, (GMP & cGMP).
• Operates washer and capper machines used in department.
• Accurately counts work done and keeps necessary records.
• Trays on containers and off loads work in process [WIP] to support filling windows.
• Cleans work areas as needed and documents in appropriate lob book.
• Notifies supervisor or lead person of any problems.
• Accurately completes all documentation associated with tasks performed.
• Stocks, gathers and stages manufacturing supplies and equipment.
• Gathers, stages and returns production materials as required to support manufacturing activities.
• Cleans and stores manufacturing equipment and areas as required to support manufacturing activities.
• Sanitization/disinfection of components, materials and production supplies to support the manufacturing process.
• Becomes gown qualified, maintains training status and wears gamma irradiated garments consisting of a coverall, hood, mask, gloves, boots and goggles.
• Becomes qualified cleaner for the aseptic processing area.
• Attends all training programs as required by Company SOPs, procedures and policies.
• Performs any other tasks/duties as assigned by management.
• Keeps work area clean and orderly.

Education Requirements And Qualifications

• Minimum of high school diploma or GED preferred.
• Able to pass gowning qualification and Media Fill Qualification.
• Mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment preferred.
• Ability to take feedback constructively and function in a team oriented work environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime as needed.
• Becomes qualified to don Glass Washroom and APA gowning apparel.
• Becomes qualified to perform Glass Washroom and APA cleaning.
• Becomes qualified to operate washers and capper machines.
• Becomes qualified to operate aseptic fill room independently.

Physical Environment And Requirements

• Possesses physical ability to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, masks, and protective gloves.
• PPE are essential for the health and safety of employees.
• Employee must be able to repeatedly lift and/or move up to 25 pounds.
• Employee must be able to stand for extended periods of time.

Pay

Expected Hourly Rate: $26.97