More jobs:
Quality Specialist
Job in
Indiana, Indiana County, Pennsylvania, 15705, USA
Listed on 2026-01-01
Listing for:
United Pharma Technologies Inc
Full Time
position Listed on 2026-01-01
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst -
Healthcare
Data Scientist
Job Description & How to Apply Below
Quality Specialist
The Quality Specialist will support Quality Assurance activities to ensure compliance with FDA regulations, cGMP, and company quality standards within a pharmaceutical manufacturing environment.
Key Responsibilities- Support QA activities including batch record review, deviations, CAPAs, change controls, and investigations
- Ensure compliance with FDA, cGMP, and internal quality procedures
- Assist with SOP creation, revision, and document control
- Support internal and external audits and regulatory inspections
- Review and approve quality-related documentation and records
- Collaborate with manufacturing, validation, and QC teams to resolve quality issues
- Bachelor’s degree in Science, Pharmacy, or related field
- Minimum 2+ years of Quality experience in pharmaceutical or regulated manufacturing
- Strong knowledge of cGMP, FDA regulations, and quality systems
- Experience with deviations, CAPA, and documentation control
- Good communication and problem‑solving skills
Location:
Indianapolis, IN
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