Senior-level management professional with significant experience in brand and multisource/generic pharmaceuticals, and other health-related industries including Auditing/Compliance, Quality Control/Assurance, Validation (systems and processes), Laboratory Management, Stability and Regulatory submissions. A customer-oriented professional with strong leadership, management and mentoring skills with expertise in microbiology, environmental control, investigations, product stability requirements, auditing, validation, training and employee development. Specialties:Microbiology/Environmental Monitoring, Aseptic Processing, Annex 1, Visual Inspection of Injectables, Compliance Auditing, Qualification of manufacturing systems and processing, Stability Testing and assessment, Training and Assessment, Clean Room and personnel Qualification, Annual Product Reviews, Regulatory Audits

Senior Director, Quality Assurance - Sterile Products @ Host agency and client inspections of the facility Ensure site compliance to cGMPs, EU/MHRA/IRB and DEA regulations. Review/Approve/write SOPs, specifications, review/approve validation protocols, requirement specifications and reports, Master and executed batch records, deviation reporting and CAPA. Product Release; interact, provide guidance with Business Development, Product Development and Project planning Developed site-specific targeted cGMP training From October 2012 to Present (3 years 1 month) 301 Beaver Court, Cockeysville, MD 21031Quality and Compliance Consultant, SME Microbiology, Validation Compliance @ Provide Manufacturing Process and Quality Engineering support for ongoing QA, Compliance and manufacturing functions, with primary focus on investigations and developing effective CAPA, remediation. Provide direction and support for Microbiological services, processes and practices; developed program for developing baseline environmental monitoring, assessment for routine monitoring and sanitization regimes, production area start ups for solid dose manufacturing. CPAT assessments, direction on validation activities, authoring protocols for new and existing facilities and processes. From January 2012 to November 2012 (11 months) Director, Quality Services @ Successfully transitioned the facility into a well-recognized cGMP facility for the manufacture of sterile injectables for Orphan drugs and niche injectables and biologics. Built sound quality systems which include:a robust change control system, internal auditing program and a Quality Review Board. Built client relationships of confidence in the quality systems through successive and successful regulatory and client audits. PAI support and product approval. Committed to face-to-face interaction with clients and the agency. Ensured successful reinspection of the facility for continued European distribution of clinical and commercial products. Promoted by upper management for on an interim role (approximately one year) as the site Director of Manufacturing. Provided on the floor mentoring support to operators. Key Accomplishments: FDA site and PAI approvals, including site approval for the manufacture of seven commercial products and two products for Europe; EU site and manufacturing authorization approvals; Consecutive site regulatory inspections with no FDA-483s for over nine years; Author of several Training Modules including Introduction to Validation, Aseptic Processing, Manufacturing Processes. From 2002 to 2012 (10 years) Charleston, South Carolina AreaSenior Team Leader, Corporate Quality Assurance @ Project leader of Quality initiative (deviation database replacement team: TrackWise®) to implement a better system for tracking of nonconformances and CAPA. Functional responsibilities for four direct reports and eight indirect reports, which include incoming inspection/sampling of raw materials, storage and inspection of retain samples and the QC Sample Dispensary, Annual Product Reviews, Trend Exception Reports, DEA compliance. From 2001 to 2002 (1 year) Greenville, North Carolina AreaQuality Manager @ Direct responsibility for incoming quality inspection, validation, metrology, manufacturing QA, stability and Document Control. Initiated new Quality Systems for purchased facility. Developed good rapport with local FDA through implemented system improvements, and responsive management, reducing regulatory citations. Interim (over a year) site lead for the startup and validation of systems and processes for a new sterile facility which included recruiting and hiring a team of Engineers and Technical writers for protocol development and implementation. Site lead for FDA inspection for approval of the new facility including coordination and issuance of responses and corrective actions for the successful approval of the facility within three months of the inspection. Managed the Stability Department which included both commercial and R&D stability programs. Coordination/completion of any out-of-specification investigations. Successfully filed supplements for stability protocols for bracketing and matrixing, (reducing costs for laboratory testing, and product costs associated with sampling). Reduced turnaround times for stability testing and submission and significantly reduced nonconformances. Authored Annual Product Reviews for all (112) marketed products, including the assessment of historical release data for trends and the implementation of the action limits program, assignment of action, release and stability limits. Improvements were implemented as a result of these reviews, Alternate to the Director of Quality Assurance for the review and approval of all Validation Protocols and final reports, environmental alert investigations for all manufacturing areas, Engineering Drawings and reports and other laboratory alert reports and investigations. From 1989 to 2001 (12 years) Tampa/St. Petersburg, Florida AreaManager, Microbiology @ Key Accomplishments: Validation Lead for new aseptic filling suite start-up; Developed microbiological culture formulation for the qualification of aseptic ointment fillers; eliminated overtime rate from 20%. Manager, Microbiological Services Altana, Inc. (Byk-Gulden Gmbh) Melville, NY Product lines include lotions, ointments (sterile and topical), creams, solutions, injectable products (including ampoules) Manager, Microbiological Services Validation Lead for new aseptic filling suite start-up which included successful media fills, HVAC qualification/requalification. Traditional culture media could not be used for the validation of aseptic ointment fillers: Developed microbiological culture formulation which could be sterilized in-situ for the qualification of aseptic ointment fillers. Through improvements in organization, planning and training/cross-training a staff of sixteen technicians and laboratory support personnel, was successful in eliminating overtime rates from 20%. In-process and finished product release testing (microbiological assays, sterility testing, and environmental monitoring) and validation activities. Implement the validation of HVAC, water, steam and ETO sterilization processes and clean-steam systems. From 1986 to 1989 (3 years) Melville, New YorkQA Supervisor @ Key Accomplishments: liaison for FDA site and PAI approvals, Government contract inspections; Product lines include tablets, capsules (including controlled release), ointments, creams, and solutions, injectables (solutions, lyophilized products, contrast imaging agents and radiopharmaceuticals). Co-lead for the startup of a new Parenteral Manufacturing facility which included: authoring Protocols, Protocol reviews and approvals; review, verification and approval of system drawings; validation of all support systems (Clean Steam, CIP/SIP, WFI, Vacuum, HVAC, Aseptic Filling Lines, and sterilization systems) which were successful in remediating observations for a previous facility . Site lead for FDA inspections for the existing and new facility as well as government contract inspections. Quality Assurance Supervisor Conducted audits, both internal and external. Supervised six Quality Assurance inspectors, and systems validations (WFI, Clean Steam HVAC, and SIP/CIP) for a new parenteral facility. From 1978 to 1986 (8 years) New Brunswick, New JerseyMicrobiology Supervisor @ -Perform and supervise the sterility testing and environmental monitoring including media preparation, growth promotion, and microbiological identifications. -Supervised sterilization validation activities for ethylene oxide, gamma and e-beam sterilization. From 1971 to 1978 (7 years) East Rutherford, New Jersey

MS, Microbiology @ Seton Hall UniversityBA, Biology @ Marist College Kevin O'Loughlin is skilled in: Reviews, Quality Auditing, Regulatory Audits, Aseptic Processing, Validation, GMP, FDA, CAPA, Change Control, Quality System, V&V, GxP, 21 CFR Part 11, Quality Assurance, Manufacturing, Sop, Quality Control, GLP, Pharmaceutical Industry, Technology Transfer, Microbiology, SOP, Sterilization