Filling Operator II
5 days ago
About the Role
This position is a member of the Manufacturing Team at American Regent, Inc. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company Standard Operating Procedures (SOPs), policies, and current Good Manufacturing Practices (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.
Key Responsibilities
- Gathers, stages, and returns production materials in support of manufacturing activities.
- Assists team members with equipment assembly, cleaning, and storage as required to support manufacturing.
- Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities.
- Staffs various stations in support of container washing, filling, stoppering, and capping. Will offload finished product.
- Ensures that only approved documentation and procedures are utilized.
- Oversees production supply, materials, and equipment gathering, staging, and sampling activities required to support manufacturing.
- Oversees and performs Quality Control (QC) sampling activities required to support manufacturing.
- Ability to perform minor machine diagnostics and repairs as required.
- Attends all training programs as required by Company SOPs, procedures, and policies.
- Performs any other tasks/duties as assigned by management.
Requirements and Qualifications
- High School Diploma or General Educational Development (GED) required. Technical degree and/or some college in a relevant field is a plus.
- Minimum one year as a Filling Operator I, having performed at a satisfactory level or 2 years similar work experience in a related field preferred.
- Ability to perform basic mathematical calculations.
- Possesses mechanical aptitude with the ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment.
- Ability to stand in one place for prolonged periods of time, monitoring equipment and processes.
- 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.
Physical Environment and Requirements
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. Personal Protective Equipment (PPE) and Respirators are essential for the health and safety of employees.
- Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
- Employee must be able to occasionally lift and/or move up to 50 pounds.
- Physically able to work using restricted access barrier (RABS) or isolation containment devices.
- Physically able to stand for long periods of time.
- Must maintain cleanroom gowning and respirator fit testing requirement.
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