Quality Assurance Specialist – Pharma Stability Data

cardinalhealth

Massachusetts

On-site

USD 63,000 - 80,000

Full time

5 days ago

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Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k

HSA

FSAs

Parental leave

Paid time off

Job summary

Cardinal Health in Mansfield, MA is seeking a Quality Specialist to execute quality programs and support data integrity. You will review processes and documents, develop SOPs, and collaborate with senior specialists to build technical capabilities.

This role emphasizes GMP/GDP/GLP compliance, data review of stability studies, and timely communication with QA. You will help with change controls, regulatory inspections, and staying current with industry guidelines while advancing quality

Qualifications

Bachelor's degree in chemistry, pharmacy or related field, or relevant work experience.
0-2 years in pharmaceutical QC or similar.
Basic QA/QC concepts and GMP/GDP/GLP familiarity.
Experience with quality systems (Veeva, Agile) and LIMS (LabWare) a plus.
Strong attention to detail and clear communication.
Ability to work in a fast-paced, cross-functional team.

Responsibilities

Provide QC review and analyze data from stability studies to ensure compliance with quality standards and regulatory requirements.
Review analytical data and report deviations to QA leadership.
Ensure adherence to GMP, GDP, and GLP regulations.
Review and approve stability studies, SOPs, protocols, and QA documents for accuracy and compliance.
Review stability data trends and interpret to assess degradation and shelf-life.
Support change controls related to pharmaceutical testing and regulatory inspections.