American Regent, Inc. · 2 months ago
QA Specialist
Shirley, NY
Full-time
Onsite
New Grad, Entry Level
$70K/yr - $85K/yrAmerican Regent, Inc. is a company focused on ensuring quality system compliance with GMPs and documentation. The QA Specialist will assist with documentation for investigations, support regulatory audits, and maintain quality programs to ensure compliance with current practices.
Health CareMedical
Responsibilities
Under supervision, assist with documentation for the closure of investigations
Assist in gathering data for reports, metrics, Annual Product reviews, Quarterly reports and external requests
Scheduling departmental meetings, maintaining meeting minutes and attendance
Maintain departmental records and files (both electronic and manual)
Participate in cross-functional project teams as required
Support, coordinate, and assist with regulatory agency audit tasks as required in support of regulatory agency inspections
Support and maintain quality programs, policies, processes, procedures and controls ensuring compliance with current Good Manufacturing Practices (cGMP)
Keep training curriculum current
Ensure all work is performed and documented in accordance with existing company policies and procedures
Perform any other tasks/duties as assigned by management
Qualification
Required
High School or GED diploma required
Experience working in a Quality role within a cGMP manufacturing environment required
Knowledge and understanding of quality assurance principles, controls and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc
Strong attention to detail, adherence to SOPs
Ability to work effectively in a collaborative environment
Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results
Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues
PC Skills Required (MS Word, Excel)
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
Preferred
Associate's degree or equivalent years of experience preferred
Benefits
Healthcare
Life insurance
Profit sharing
Paid time off
Matching 401k
A wide range of other benefits
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.
Founded in 1967
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