QA Compliance Specialist II

Position Title: QA Compliance Specialist II Work Location: 60064, North Chicago, IL Assignment Duration: 06 Months (Possible extension) Work Arrangement: Onsite (warehouse floor support required) Position Summary: Assure compliance with FDA current Good manufacturing Practices (cGMP) and Good Distribution Practices (cGDP) regulations. Assure compliance with Corporate policies/procedures and provide guidance on operational processes, procedural issues and documentation content and adequacy. Assess operations/distribution outages and deviations to determine compliance with specifications and procedures. Key Responsibilities: • Site CAPA Coordinator/ administrator for shipment temperature management • Audit Interface- FDA, supplier, customer inspection, corporate • Project Management for Quality Initiatives • Manage Validation Library • Conduct product quality, diversion and distribution complaint investigations • Manage warehouse temperature monitoring program • Point Person for NPI launches • Execute placement and removal of QA Holds in warehouse management system • Manage/Post supplier audit data in appropriate database • Manage market authorization process and Master Data Management Qualifications & Experience: • Bachelor's degree is preferred • 4 years in Quality Assurance, Process Support, Engineering, Manufacturing/Operations, Distribution or similar area. • Reviewing problem solving situation • Understand manufacturing / distribution process • Product responsibility for compliance troubleshooting • Audit interface • Creativity in resolving issues • Negotiation skills with Mfg. / Distribution customers • Individual is also heavily involved in the analysis of complex technical data in all aspects of product acceptance. This position is heavily involved in product and process problem solving and works closely with R&D, Process Development, Manufacturing/Operations and Engineering.

Salary : $33 - $35