American Regent, Inc., a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics, hospitals and veterinary practices across the United States and Canada. We have locations in New York, Ohio, and Pennsylvania and sales territories nationwide.
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. The Team Member will be able to participate in all aspects of the Component Prep Process. The Component Prep Process includes dispensing components (Caps and Seals), vial washing and component sterilization in accordance with established production records in a concentrated effort to manufacture sterile liquid pharmaceuticals. The Team Member will assist with all activities associated with the component prep process under the direct supervision of Senior Manufacturing Team Members.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• Performs a variety of production prep activities including component washing/sterilization.
• Complete production documentation including log books, cleaning tags, batch records, etc. per quality and cGMP requirements.
• Ensure strict adherence to and compliance with SOP’s and protocols.
• Ensure all work is performed and documented in accordance with existing company policies, procedures (SOP’s), Current Good Manufacturing Practices (cGMPs), and health and safety requirements.
• Perform any other tasks/duties as assigned by management.
• We all must embrace the QUALITY culture.
• High School Diploma or GED preferred.
• One year working experience in a production environment preferred.
• Ability to perform repetitive lifting, cleaning and stacking activities.
• Mechanical aptitude preferred.
• Ability to perform basic math including addition, subtraction, multiplication, division and calculations of averages and percentages.
• Strong attention to detail or organization skills.
• Excellent interpersonal and communication skills (oral and written).
• Demonstrated success working in a team 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.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
• Employee must be able to occasionally lift and/or move up to 50 pounds.
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.