Quality Specialist

United Pharma Technologies Inc; Indiana (PA); On-site; USD 55,000 - 70,000; Full time

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

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