American Regent, Inc. · 8 hours ago
QA Operations Associate I
Hilliard, OH
Full-time
Onsite
Entry Level
1+ years expAmerican Regent, Inc. is focused on ensuring quality in their operations, and they are seeking a QA Operations Associate I. This role is responsible for maintaining quality standards, conducting inspections, and ensuring compliance with GMP requirements in the production process.
Health CareMedical
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
Able to perform tasks with minimal error rate
Perform any other tasks/duties as assigned by management
We all must embrace the QUALITY culture
Qualification
Required
High School Diploma or GED equivalent required
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
Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred
Must be able to do work independently
Employee must be able to occasionally lift and/or move up to 25 pounds
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
Preferred
Associates or Bachelor's Degree preferred
Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred
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