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Quality Assurance Senior Associate at Keenova Therapeutics and Par Health - ApplyBlast

Quality Assurance Senior Associate

Keenova Therapeutics and Par Health

3 months ago

3.4 on Glassdoor

Onsite

Full Time

Senior

0 applicants

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About this role

A Quality Assurance professional manages shopfloor in-process quality activities, authorizes line clearances, and performs sampling and stability tests for drug products. The role involves ensuring compliance with cGMP standards, calibrating instruments, and managing reserve samples while releasing bulk materials through SAP. This position is critical for maintaining environmental management system requirements and investigating batch record errors.

Responsibilities

Execute shopfloor in-process quality assurance activities
Authorize line clearances during product changeovers
Conduct sampling and stability tests for drug products
Ensure cGMP compliance and instrument calibration
Review and approve procedures impacting drug product quality

Skills

Qualifications

Bachelor's Degree in Life Sciences

About Keenova Therapeutics and Par Health

mallinckrodt.com

Headquarters

Dublin, Dublin, Ireland

Company Size

1001-5000 employees

Founded

1867

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Keenova Therapeutics and Par Health are the successor entities formed after Mallinckrodt's merger with Endo; Keenova Therapeutics focuses on specialty therapeutics across rare and unaddressed conditions (immunology, urology, hepatology, ophthalmology, orthopedics, critical care), while Par Health develops high-quality generics, sterile injectables, and active pharmaceutical ingredients (APIs) with a robust U.S.-advantaged manufacturing network.