American Regent, Inc. · 3 months ago
QA Operations Materials Associate
New Albany, OH
Full-time
Onsite
Entry Level
2+ years expAmerican Regent, Inc. is a company committed to ensuring quality in its operations. The QA Operations Materials Associate is responsible for executing site policies and procedures, ensuring compliance with GMP requirements, and coordinating the sampling and inspection of materials in a sterile manufacturing environment.
Health CareMedical
Responsibilities
Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes
Performs sampling of components
Conduct verifications and checks through accurate material inspections
Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system
Management of BPCS for verification and disposition of materials
Maintain retain samples for all primary and secondary components and labeling
Performance of DAF (Destruction Approval) process for rejected materials
Use of Trackwise and Veeva for change controls, as needed
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
Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation
Support generation of logbooks and sheets/labels as required
Basic knowledge of cGMPs and supporting regulatory documents
Perform room, area and equipment clearances that may be necessary for this job function
Able to perform tasks with minimal error rate
Assist other Quality Assurance Operations Associates, as needed
Perform any other tasks/duties as assigned by management
Qualification
Required
High School Diploma or GED equivalent required
Must be able to do work independently
Strong analytical skills, attention to detail and adherence to procedures
Intermediate skills in Microsoft Word and Excel are 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
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision
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 25 pounds
Preferred
Associates or Bachelor's Degree preferred
At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred
Experience in QA working in a cGMP manufacturing environment (preferred)
Working knowledge and understanding of quality assurance principles and familiarity with QA programs
Company
American Regent, Inc.
American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.
501-1000 employees
H1B Sponsorship
American Regent, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (10)
2023 (4)
2022 (5)
2021 (8)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Paul Diolosa
President & CEO
Joseph Boyle
VP Finance / CFO
Recent News
GlobeNewswire
2026-01-09
thefly.com
2025-08-28
Company data provided by crunchbase