Senior Quality Assurance Specialist
$84,000–$100,000 year
On-site · Chicago, Illinois, United States
Job Summary
Senior Quality Assurance Specialist coordinates QA activities to ensure Meitheal’s batch disposition, QA documentation, and regulatory compliance for commercialized products. Responsibilities include review and approval of batch records, COA/COC and quality documentation, assessment of partner investigations for root cause analysis, review of temperature profiling data, lifecycle management activities (packaging specs/assessments, shipping assessments, process validation reports for commercialized products), handling internal quality events (deviations, investigations, risk assessments), providing cGMP guidance, support for New Product Launches, and assisting with external inspections. Requires strong knowledge of CFR/cGMP, SOPs, and quality systems; travels no more than necessary, and collaboration with partners to ensure compliant, high-quality product shipments.
Required Qualifications
- Bachelor’s degree in science or equivalent degree
- 3-5 years’ experience in Quality with a pharmaceutical company or similarly regulated industry
- Background in GMP/GDP, sterile injectables preferred
- Strong written and oral communications skills
- Must be a strong team player with good problem solving and good verbal and written communication skills
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