Quality Specialist

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 #J-18808-Ljbffr