Kelly Devine Email & Phone Number

Ann Arbor, Mi, Us

Ann Arbor, Mi

Chief/Sr. Supervisor, Quality Assurance-Surgeon Products/Strategic Relationships/Corporate Supplier Quality Engineering (7/2010-present)-Develop and Maintain proper compliance and Quality Systems requirements for Purchasing Controls-Manage New Supplier Audits Program and Evaluation activities (Supplier Performance Scorecards)-Foster Quality culture changes under Consent Decree-Prepare Health Hazard Evaluations (HHEs) for Regulatory Affairs Recall process-FDA Audit Response Team - Coach/Reviewer/ Subject Matter Expert (SME) for Distributed Products-Advise Corporate Supplier Quality Engineering, Purchasing Controls and Supply Chain Management-Conduct assessments of suppliers’ quality control systems, capabilities, processes and facilities

Livonia, Mi

-Develop and Implement Quality System for proprietary Clean Room Contract Service Organization (CSO)-Develop and Validate Analytical Test Methods and Manufacturing Processes -cGMP/GLP Training for Cleanroom and Lab Technicians-Host Quality Audits for new and existing customers (Boston Scientific, Catalent, Donatelle and Chanel)-Maintain Quality compliance for a variety of industries (medical device, pharma, aeronautic, electronic)

Greater Nashville Area, Tn

-Design, Build and Validate cGMP pharmaceutical pilot plant for New Drug Application (NDA)-Develop Contract Manufacturing business services (CMO) including webpage for marketing-Foster new relationships and increase profitable opportunities for topical products-Advise/Direct competitive marketing plan -Plan and direct organization structure and function-Develop protocols for NDA filing for clinical trial drugs-Manage and audit vendors, suppliers and contract services -Review/Approval of: Standard Operating Procedures (SOP), Product Specifications and Acceptance Criteria, Master Batch Records, Raw Materials, Product release, Validation, Stability, Analytical Reports

Dearborn, Mi

Consultant position – towards a Master’s degree in Organization Management (MAOM). Double Eagle Steel Coating- Quality SOP Consultant (08/2007-10/2007)-Audit laboratory and production facilities -Implement TS-16949 quality protocols for laboratory

Toledo, Ohio Area

Consultant position – towards a Master’s degree in Organization Management (MAOM). Develop formal personnel training plan for clients Project Management for Premier clients (General Electric, Ford, Boeing) On-site audits for validation of new product lines

Greater Detroit Area

Consultant position – towards a Master’s degree in Organization Management (MAOM).-New Product Development Quality standards for prototype PET plastic beverage containers (Pepsi, Coke, Private Labels)- Project Management, FMEA and Design of Experiments (DOE) approach analysis-Internal Audit (Quality laboratory and manufacturing facilities)

Greater Detroit Area

Consultant position – towards a Master’s degree in Organization Management (MAOM).Lead ISO-9001audits for automotive parts (Textron, General Motors) Develop Statistical reports and analysis on effectiveness of on-site contract inspection services

Lansing, Mi

-Continuous improvement Test Methodology for chemical and biological analysis of Anthrax Vaccine-Validation protocol for production quality WFI (Water for Injection) -Efficient review and release of bio-analytical data for JIT (Just-In-Time) production schedule

Greater Detroit Area

-Design/Implementation of several regulatory programs (Vendor Qualification, Retains, Stability, CAPA) -R&D, Pilot Production for Chemotherapy drugs (US Government sponsored Orphan grants)-Manage/Train and Mentor Quality Control Chemists-Ensure compliance of lab instruments and mfg equipment-Validation Engineer for equipment and facilities (Environmental Monitoring, WFI systems) -Environmental Controls/Analytical Equipment/Metrology and Calibration (IQ, OQ, PQ)-Develop/Validate process and product protocols (HPLC, GC, Clean room and equipment verification)

Detroit Production

-Responsible for Production Quality of Coca-Cola brand products, packaging and promotions-Release/Quarantine of products and raw materials -Train and Manage Quality Control Chemists -Perform cGMP/GLP training sessions for laboratory and production personnel-Write and review SOPs-Optimize production adjustments to meet target yield.-Develop Analytical Test Methods for new products (HPLC, wet chemistry)-Conduct In-house audits of laboratory and production floor

Rochester, Mi

-Develop Analytical Test Methods for various injectable drugs (Influenza Virus Vaccine, Epinephrine) -Exclusive R&D work for proprietary products (HPLC, GC, UV, Wet Chemistry)-Verify and Release raw materials, bulk solutions and finished products-Protocols for Compendia/USP approved and new ANDA/NDA clinical trial drugs -Validation studies for products and manufacturing processes -Write and Review Analytical research reports and batch records -Teach new analysts Good Manufacturing/Laboratory Practices (cGMP/GLP) under Consent Decree

Phd Doctoral Candidate, Organizational Leadership, 3.9

Master'S Degree, Organization Management

Bachelor'S Degree, Biochemistry