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QA Technical Services Specialist III at American Regent - ApplyBlast

QA Technical Services Specialist III

American Regent

3 months ago

3.7 on Glassdoor

New Albany, OH

Hybrid

Full Time

Senior

0 applicants

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About this role

The QA Technical Services Specialist III leads technical and quality compliance reviews and audits for cGMP documentation, including validation of critical equipment, utilities, facilities, and analytical data. This autonomous role assists the Quality Assurance Manager by managing project teams, implementing regulatory changes, and ensuring adherence to quality systems and safety requirements across multiple Ohio locations.

Responsibilities

Lead technical and quality compliance reviews and audits for cGMP documentation
Identify and resolve potential quality risks using quality risk management principles
Manage investigations and continuous quality improvement initiatives independently
Review and approve validation reports for methods, processes, and equipment
Support regulatory inspections and on-site cGMP audits performed by external providers

Skills

Qualifications

BS or MS in Life Sciences, Chemistry, Pharmaceutical Science, or related fieldFive years of pharmaceutical experience in QA, Regulatory Compliance, or cGMP auditing

About American Regent

americanregent.com

Headquarters

Shirley, New York, United States

Company Size

501-1000 employees

Founded

1910

View Profile

American Regent is a pharmaceutical company dedicated to developing and reliably delivering essential injectable medicines for both human and animal health. Their product portfolio includes a wide range of injectable drugs such as Epinephrine, Venofer® (iron sucrose injection), Injectafer®, and many other USP-grade medications. headquartered in Shirley, NY, American Regent is a subsidiary of the Daiichi Sankyo Group.