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Alan E.

Alosio 33721 Old Bridge Road Dana Point, California 92629 Operations / Senior-Level Management Background encompasses 13 years as Vice President Operations/Quality/Compliance preceded by 14 years in Manufacturing, Quality and R & D for Fortune 500, middle -market and small companies. In-depth experience in company operational functio ns including manufacturing, quality and inventory in a regulated environment. Strong focus on product quality with the emphasis on the customer. Lean manufa cturing and Six Sigma methodologies. Consistently established and enhanced qual ity and operational systems and procedures to assure regulatory compliance and r educe cost of doing business. Strategic and Operational Management Competencies * * * * * * * Operational Strategic Planning * Hands-on Leadership Cost Reduction Initiatives * Departmental Restructuring Process/Product Validation * Cost Reduction Initiatives Problem Solving * Internal and External Auditing Lean Manufacturing Techniques * Six Sigma Training Budgeting/Variance Analysis * Compliance Assurance Supplier Relationships 949.310.9769

Professional Experience Consultant March 2008 present

Provide quality and manufacturing systems, procedures and practices support of c ompany directives and applicable regulatory requirements. Represent client for regulatory agency or 3rd party audits. Results: Enhanced manufacturing practice based upon CAPA and customer complaints resulti ng in ability of line to operate continuously Identified and quantified equipment and facility requirements for a new product family resulting in companys ability to provide additional product types to cus tomers. Representative for FDA and 3rd party audits pertaining to OTC and nutraceutical product areas resulting in attainment of 3rd party certification.. Reorganized/staffed the Quality department from within thus enhancing company q uality strength, support and efficiency Assisted in consolidation of multi-site Quality systems resulting in a singular system for several aspects of ISO regulations Developed/Enhanced, documented and implemented a quality system resulting in 3r d party certification

Vice President of Operations/Quality/Compliance MICELLE LABORATORIES Lake Forest, California Sept 1995 to March 2008 Senior Operational Management for a contract manufacturer of nutraceuticals and OTC pharmaceuticals with $25 million in annual sales. Hired to enhance producti on/quality processes and systems to support growing customer base and regulatory requirements. Departmental budgeting, product costing and capital equipment fo

recasting. Primary interface for all FDA and 3rd party audits and certification s. Provide GMP training. Team member with other Senior management for new cust omer relationships as customer expectations and specifications are established. Direct responsibility for all aspects of Operations including, manufacturing, q uality, purchasing, inventory, maintenance, warehouse, planning and compliance. Supervised staff of 80 employees with 7 direct staff members. Operational budg eting and capital equipment planning to support company goals and directives alo ng with metrics and variance analysis allowing Principals stay on target with st rategic objectives. Implemented fully compliant GMP system supporting manufacture of OTC pharmaceuti cals and nutraceuticals. Designed and executed an 110,000 square foot manufactu ring relocation initiative. Added new product capabilities supporting three n ew product types. Enhanced processes lines through automation. Results: Established and implemented a Quality System resulting the attainment of an FDA OTC Drug License and an increase in customers, 2 minimum Reviewed and revised purchasing policies and procedures resulting in reduction in inventory of $500,000 Researched and implemented a new production line providing retention of largest customer, reduced product labor costs by 50% and product costs by 10% Evaluated, cross-trained and reduced personnel reducing overhead and direct lab or costs by 15% Implemented process enhancements through equipment purchases and line modificat ions...Result: improved efficiency while reducing costs and labor expenses in mu ltiple companies Restructured liquid mixing line providing for easier cleaning and flexibility r educing downtime for cleaning in half and assuring a clean system Quality and Compliance Manager LAERDAL MEDICAL Long Beach, California

1992 to 1995

Senior Quality department head of a first response medical device manufacturer. Responsible for all company quality aspects from incoming inspection through wo rk-in-process to final release. Established and implemented a documented qualit y system including Change Control system. Primary FDA interface for audits and regulatory correspondence including 510k submission. Established and implemented a fully GMP compliant quality system along with top down training GMP. Supported regulatory issues and primary interface for all FD A audits. Established inspection procedures from incoming material throughout p rocess to final release. Results: Full GMP compliant system allowed company to continue marketing 510k products Implementation of inspection methodologies improved incoming material quality t hereby increasing production yields by 2% and reducing product variation. Provided GMP and Quality training to all personnel enhancing awareness and prod uct quality. Regulatory submission allowed release of new product to the marketplace. Quality Manager ADVANCED INTERVENTIONAL SYSTEMS Irvine, California

1990 to1992

A start-up company manufacturing Excimer lasers and fiber-optic catheters for co ronary angioplasty. Hired on to complete implementation of Quality systems, ins pection programs and environmental monitoring. Responsible for all Quality func

tional areas related to the manufacture, inspection, record retention and regula tory auditing of a laser and laser catheters utilized for angioplasty. 4 direct reports supporting in-house and contracted manufacturing. Established and implemented inspection program and reporting metrics providing d irect insight to manufacturing issues and nonconformances. Upgraded laminar flo w enhancing environmental conditions in cleanrooms along with proper matting in ante-rooms. Results: Completion of Quality system allowing company to continue marketing product lin es. Establishment of inspection practices increased released material quality there by improving production output and product quality.

Production Manager/ Quality Engineer SHILEY INCORPORATED (a division of Pfizer) Irvine, California

1987 to 1990

Originally hired on as Quality Engineer supporting the tracheostomy tube, subcla vian cannula, embolectomy catheter, cardiac pads and auto transfusion set manufa cturing areas. After one year promoted to Manufacturing Manager for the same pr oduct families with goal to increase tracheostomy production 40% to keep up with demand. Managed 120 employees, 4 direct, over two shifts. Established departm ental budgets and assisted in development of new products. Results: Increased tracheostomy production 40% to keep pace with market thus eliminating backorder. Implemented new product lines enhancing companys product base Represented functional area(s) during regulatory audits supporting successful a udit results Quality Engineer, Documentation Control Supervisor, R&D Engineer ALLERGAN MEDICAL OPTICS (a division of Allergan) Irvine, California 87

1983 19

Recruited initially as R&D Engineer and earned two performance based promotions leading to Quality Engineer. Tasked with engaging in product design, process de velopment and testing of intra-ocular lenses and YAG lasers. Collaborated with ophthalmologists to ensure feasibility of design and performa nce. Enhanced Documentation system adding label copy control and developed departmen t and departmental procedures Introduced, qualified and developed quality system supporting laser product lin e Associate Engineer, Designer IOLAB (a division of Johnson & Johnson) Claremont, California

1981 - 1983

Intra-ocular lens design and testing. Designed configurations and structure layo uts. Developed and qualified new product design and processes.

Education Bachelor of Science, Electrical Engineering, (Biomedical Engineering emphasis) California State University, Long Beach, CA Member: American Society for Quality (ASQ) Available to relocate