MQA Specialist II
Core
Performs routine audits of manufacturing areas to ensure product quality and SOP/GMP compliance at the Melrose Park Manufacturing Facility.
Role type
Quality Assurance Specialist (Manufacturing)
Builds
Pharmaceutical and medical device products
Domain
Pharmaceutical manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work
Required skills
GMP compliance, SOP adherence, deviation management, CAPA initiation, root cause analysis, aseptic technique, microbiology knowledge, data governance, visual inspection (AQL), sterilization review, packaging oversight, warehouse storage compliance, audit trail verification, batch record review
Preferred skills
Bachelor of Science degree, 5-10 years experience in pharmaceutical/medical device/food industry, knowledge of computerized systems, Excel/Word/Access proficiency
Technologies
Computerized systems, audit trail software, Excel, Word, Access
Responsibilities
Conduct shop-floor audits for quality and compliance, stop production during critical deviations, escalate issues and propose CAPAs, monitor in-process controls and filling/lyophilization activities, perform visual inspections and defect evaluation, oversee sterilization and packaging, collect and analyze inspection data, review and approve procedures and batch records, support troubleshooting of manufacturing problems, prepare for internal and external audits
Seniority
Mid-level, hands-on IC