United Pharma Technologies Inc
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
Required Qualifications
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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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
Required Qualifications
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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