Nature and Scope
This 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 sterilizing small and large pieces of equipment, and aseptic filling in accordance with established production records in a concerted effort to manufacture safe, effective and sterile liquid pharmaceuticals. The Filling Process includes loading of glass vials, plastic bottles, caps, tips, and seals into manufacturing machinery, operation of filling machine, operation of capping machine, unloading of finished product from the manufacturing machinery and the tear-down and line clearances of the manufacturing equipment. The Team Member will be proficient in all activities associated with the filling process and be able to work with minimal supervision. The Team Member will, with assistance from a Senior Team Member/s, be able to troubleshoot minor equipment adjustments and repairs during setup and during operations.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
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Assists all team members with equipment assembly and cleaning as required to support manufacturing activities.
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Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities.
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Assists with equipment and operating supply inventory control.
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Staffs filling line operating stations in support of filling, stoppering, and capping operation.
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Ensure that only approved documentation and procedures are utilized.
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Oversee production supply, materials and equipment gathering and staging activities required to support manufacturing.
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Ability to perform minor machine diagnostics and repairs as required.
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Attends all training programs as required by Company SOPs, procedures and policies.
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Perform any other tasks/duties as assigned by management.
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We all must embrace the QUALITY culture.
Qualifications and Requirements
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High School Diploma or GED preferred.
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At least 1 year as a Filling Operator I, having performed at a satisfactory level or 2 years similar work experience in a related field is preferred.
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Ability to perform basic mathematical calculations.
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Possesses mechanical aptitude with the ability to assemble, troubleshoot and perform minor repairs on manufacturing equipment.
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Ability to take feedback constructively and function in a team oriented work environment.
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Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
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Ability to work overtime as needed.
Physical Environment and Physical Requirements
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Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
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Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
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Employee must be able to occasionally lift and/or move up to 25 pounds.
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.
Applicants have rights under Federal Employment Laws.
FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
- All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
- Our recruiting process includes multiple in person and/or video interviews and assessments.
- If you are unsure about the legitimacy of a message, contact John Rossini at [email protected] before responding.
- We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
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