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American Regent, Inc. · 8 hours ago

Quality Engineer

Shirley, NY

Full-time

Onsite

Mid Level

$80K/yr - $90K/yr

3+ years exp

American Regent, Inc. is a company that focuses on meeting industry and customer requirements through quality assurance. The Quality Engineer is responsible for providing Quality Assurance input to validated systems, preparing and reviewing protocols, and collaborating with various departments to resolve quality issues.

Health CareMedical

H1B Sponsor Likely

Responsibilities

Preparation/review of Quality Assurance, Validation, and Quality Control protocols and reports covering complex systems such as Process Validation, computer-controlled systems validation, complex utilities, complex manufacturing equipment such as filling systems, formulation systems and knowledge of laboratory validation

Works closely with other members of plant quality, manufacturing, calibration services and R&D organizations to accomplish overall objectives; and understand cGMP, and other FDA Guidance Documents, as well as the current processes and practices that are current and ongoing at the American Regent manufacturing/packaging site

Identify key quality issues and assist their resolution

Employ knowledge of process improvement techniques and tools such as the DMAIC model, FMEA, process Flow Diagram, Affinity Diagram, Pareto, Control Charts (SCP) Run Charts, SOP etc

Perform any other tasks/duties as assigned by management

Qualification

CGMP knowledgeFDA regulationsTechnical writingProcess validationQuality AssuranceProcess improvementMicrosoft OfficeTeam collaborationDocumentation Practices

Required

Minimum of 3 years in an FDA regulated environment required, preferably in an Engineering or Validation capacity

Bachelor's degree in Engineering or Science, required

Strong working knowledge of cGMP and Federal (FDA) requirements and guidelines

Strong technical writing skills and knowledge of Good Documentation Practices

Strong knowledge of computer software including Word, Excel, and PowerPoint

Ability to interface with senior level employees from multiple departments

Preferred

Master's degree 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

Shirley, New York, USA

501-1000 employees

http://www.americanregent.com/

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)