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QA Operations Associate IAmerican Regent, Inc. • New Albany, Indiana, United States
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QA Operations Associate I

American Regent, Inc.
  • US
    New Albany, Indiana, United States
  • US
    New Albany, Indiana, United States
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About

Overview Nature and Scope: This position is responsible for ensuring overall quality in assigned areas through the execution of site policies, procedures, programs, and work instructions. It ensures all processes and products meet specifications and are produced in accordance with GMP requirements. Responsibilities Achieve and maintain packaging line and inspection room clearance qualification Conduct accurate verifications and checks as well as accurate process inspections Conduct accurate packaging AQL inspections Identify out‑of‑specification product, ensuring segregation and escalation as required Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements Ensure all work is performed and documented in accordance with existing company policies and procedures, as well as cGMP, health and safety requirements Conduct component and raw material release Conduct chart monitoring, ensuring escalation as required Support product shipping activities and perform quality‑related oversight and verifications Generate logbooks and sheets/labels Review Bills of Materials Basic knowledge of cGMPs and supporting regulatory documents Achieve and maintain clean side gown and sterile side gown qualifications Achieve and maintain Class A qualification Perform room, area and equipment clearances Participate in Media Fill and maintain qualification Perform tasks with a minimal error rate Perform any other tasks/duties as assigned by management Education Requirements and Qualifications High School Diploma or GED equivalent required Associate's or Bachelor's Degree preferred Minimum 1 year work experience in a FDA‑regulated environment or similarly regulated area preferred Must be able to work independently Intermediate skills in Microsoft Word and Excel required Excellent organizational, interpersonal, and communication skills (written and oral) required Ability to take feedback constructively and function in a team‑oriented work environment Ability to work overtime as needed Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including gowning, goggles, face shields, respirators, and protective gloves PPE and respirators essential for health and safety of employees Specific vision requirements: 20/20 near vision (correctable with eyeglasses or contacts) and color vision Maintain a clean‑shaven appearance each shift to wear tight‑fitting respirators properly Occasionally lift and/or move up to 25 pounds Equal Opportunity Employer American Regent celebrates diversity and is 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.
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  • New Albany, Indiana, United States

Languages

  • English
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