Morciglio current resume 2016

Download Morciglio current resume 2016

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JENNIFER JOY FRANKLINCHRISTOPHER MORCIGLIO CMORCIGLIO8872@YAHOO.COM55 Copperdale Drive, Simpsonville, SC 29681 (C) 845-598-7645 MANAGEMENT PROFILE A highly skilled pharmaceutical professional with broad-based experience Quality Assurance Manufacturing Packaging Quality Control New Product Launches Proven track record of launching new products with Third Party Suppliers. Excels at building quality customer relationships, both internal and external. Cross-functional team leader with ability to motivate and partner all customers Strong negotiation, persuasion, problem solving, and persistence skills.04/16 PresentPatheon, Incorporated, Greenville, SC 29605Senior Manager, Quality Control-Direct supervision of 18 laboratory chemists, data reviewers, and lab assistants-Daily interface with internal teammates in Production, QA, Engineering, and EHS to achieve on-time delivery of Active Pharmaceutical Ingredient (API) by effective scheduling and prioritization of sixteen (16) unique active projects-Serve as QCs face to the customer for ongoing projects, from clinical all the way through commercialization-Evaluation/review/approval of OOSs, DRs, PQIs, OIs, Validation Protocols, Process PQ Protocols, Method Validation Protocols and Approval Reports, Method Transfers, Stability Reports-Composition of Reference Standard Requalification Protocols for customer information/approval-Engages in sitewide improvement initiatives as member of Site Leadership Team (SLT)-Hosts visitors to the QC Lab on site visits or audits-Served as QC Owner of Organization Excellence (OE) initiatives and GLASS project, bringing Empower to QC09/11 04/16Watson/Actavis/Allergan, Parsippany, NJ 07054 Manager, Third Party Quality Assurance-Provide management and quality oversight of one hundred twelve products, across nineteen different TPMs.-Provide review and approval of protocols, reports, investigations, change controls and/or deviations associated with process validation, method validation, shipping studies, routine production, process changes, Regulatory and audit findings.-Currently managing eighteen products in either R&D or pre-launch stage-Provide QA support for customer complaint tracking, trending and closure-Review and approval of incoming APRs from TPMs, initiating feedback and dialogue where needed-Saw opportunity to reduce cost of stability spending by company by eliminating testing past expiration date. Savings would be in excess of $365K. Removal of other time points is under evaluation. -Developed, with site USP liaison, a compendial compliance program for tracking our TPMs USP compliance08/09 09/11Purdue Pharma, LP, Totowa, NJ 07512Manager, Supplier Quality Assurance-Quality oversight of four projects from four different CROs/CMOs, with successful January 2011 launch-Quality review and signoff of Method Validation Protocols, Product Specifications, Master Batch Records, Stability Protocols, Analytical Methods and Validation Reports in support of launch/commercial needs.-Review/audit executed and non-executed batch records and perform final QA release of product.-Investigation and completion of OOS and OOT results, both internal and external and respective CAPAs from incidents occurring at third party CMOs.-Customer complaint closure, up to and including investigation and approval.11/04-08/09Barr Labs, Pomona, NY 10970Senior External Quality Associate-Quality review and signoff of Method Validation Protocols, Product Specifications, Master Batch Records, Stability Protocols, Analytical Methods and corresponding Validation Reports.-Facilitation of the achievement of objectives leading to ANDA submissions, including adherence to project timelines regarding quality/production/packaging document signoff and approval, protocol signoff and approval, analytical test method signoff and approval, and final report signoff and approval.-Review/audit executed and non-executed batch records and perform final QA release of product. -Write internal and evaluate external investigations, deviations, CAPAs and change controls.-Review and prepare specifications for raw materials and finished products.-Investigation and follow-through to completion of OOS and OOT results generated at third party CMOs.01/04 11/04Vyteris Inc, Fairlawn, NJ 07410Analytical Services Auditor-Review of laboratory-generated data for stability, release and protocol efficacy demonstration-Review of protocols, SOPs, and IQs, OQs, PQs for content and regulatory compliance-Performed internal compliance audits of the laboratory areas and their related functions -Conducted training sessions for laboratory scientists and technicians, covering documentation, regulatory compliance, and test method improvements-Performance of internal investigations, including Out of Calibration Investigations, Out of Specification Investigations, and internal audit follow-ups11/03 12/03Mustang Biopharm, Philadelphia, PA, assignment in Pearl River, NY, Wyeth LaboratoriesPharmaceutical Consultant - Temporary-Organizing and facilitating the creation of PMOs for both GMP critical and non-critical instrumentation08/95 11/03Novartis Pharmaceuticals Corporation, Suffern, New York, 10901 12/97 11/03 Chemist, Quality Control Unit-Performed finished product and stability testing on over fifteen different finished goods.-Troubleshooting of analytical and instrumentation problems, and performance of internal audits and investigations.-Validation of paperwork and batch work needed for batch release and ongoing stability.12/96 12/97 Manufacturing Supervisor, Compression/Capsulation/Branding -Ensuring that production objectives for units are set and met, as well as integration of company goals.-Maintain a positive work environment, foster a positive/supportive culture, and boost morale whenever possible.-Ensuring of product quality within the business, First Time Right.-Support of technical training for the unit to include equipment, product and process training, cGMPs, SOPs, HAZCOM, and safety.12/95 12/96 Supervisor, Quality Assurance-Monitoring of the sites manufacturing, packaging, and warehouse operation to assure compliance with cGMPs and SOPs, via periodic and random internal audits and area checks.-Making decisions as to whether or not production operations should begin, continue, or be modified.8/95 12/95 Inspector, Quality Assurance-Inspection of integrated packaging and transdermal lines to ensure cleanliness and readiness for operation.-Performance of in-process tests and review of completed batch records 9/94 4/95Lederle Laboratories, Pearl River, New YorkClinical Trials Coordinator-In-house development of mathematical/statistical representations of blind, double blind, and placebo/blind drug studies, and fabrication of clinical kits for those developed studies.EDUCATION:Saint Thomas Aquinas College, Sparkill, New York, 10976Bachelor of Science degree in Chemistry with specialization in Natural Sciences, May 1994, Cum Laude