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 ensure 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.

The Team Member will be able to participate in all aspects of the Filling Process. The Filling Process includes dispensing components, cleaning, assembling, and sanitizing small and large pieces of equipment, and aseptic filling in accordance with established production records in a concerted effort to manufacture sterile liquid pharmaceuticals. The Filling Process includes loading of glass vials, stoppers, caps, and seals into manufacturing machinery, operation of filling machine, operation capping machine, unloading of finished product from the manufacturing machinery and the line clearances of the manufacturing equipment. The Filling Operator I will assist with all activities associated with the filling process under the direct supervision of a Filling Operator II-III, Lead and/or supervisor.

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).

• Perform duties according to the company's standard operating procedures, (SOPs).

• 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.

• Required to become gown qualified, maintain training status and wear gamma irradiated garments consisting of a coverall, hood, mask, gloves, boots and goggles.

• Required to become qualified cleaner for the aseptic processing area.

• Attends all training programs as required by Company SOPs, procedures and policies.

• Perform 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.

• Must become qualified to don Glass Washroom and APA gowning apparel.

• Must become qualified to perform Glass Washroom and APA cleaning.

• Must become qualified to operate washers and cappers.

• Must become qualified to operate aseptic fill room independently.

Physical Environment and Requirements

• Physically able 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.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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