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Job summary
A leading pharmaceutical company in Indiana is seeking a Quality Specialist to support Quality Assurance activities within a manufacturing environment. The ideal candidate will ensure compliance with FDA regulations and cGMP while supporting QA processes, assisting with audits, and resolving quality issues. A Bachelor's degree in Science or Pharmacy and 2+ years of relevant experience are required. This role offers a chance to impact quality assurance in a critical industry.
Qualifications
Minimum 2+ years of Quality experience in pharmaceutical or regulated manufacturing.
Experience with deviations, CAPA, and documentation control.
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.
Skills
cGMP knowledge
FDA regulations expertise
Problem-solving skills
Strong communication
Education
Bachelor’s degree in Science, Pharmacy, or related field
Job description
A leading pharmaceutical company in Indiana is seeking a Quality Specialist to support Quality Assurance activities within a manufacturing environment. The ideal candidate will ensure compliance with FDA regulations and cGMP while supporting QA processes, assisting with audits, and resolving quality issues. A Bachelor's degree in Science or Pharmacy and 2+ years of relevant experience are required. This role offers a chance to impact quality assurance in a critical industry.