Manager Quality

Professional Career History

COMMUNITY BLOOD SERVICES (Blood Systems Inc. Affiliate Member) (March 2004 – February 2017) Montvale, NJ

Blood and Blood Component Banking and Stem Cell collection, storage and release

I was hired in 2004 as Q.A. Technical Assistant reporting to the Director of Quality Assurance. In 2009 my position was upgraded to

Q.A. Technical Specialist, CQA (ASQ). After the BSI takeover in 2015 elevated to Quality Manager and achieved LSSYB Certification.

My responsibilities include the following:

Assist QA Director with:

oFDA and NMDP Audits of all company sites

oNew York State and New Jersey State Inspections

oAABB Assessment

As Audit Scheduler track and conduct all Internal, Supplier, and External follow up Audits which include:

oAll CBS Blood Donation Sites

oBlood Components Lab

oHospital Services

oDonor Services, including Mobiles

oWarehouse / Storage / Handling

oDeviation Management (TRACKWISE)

Facilitator of various Process Improvement Teams when required and all CAPA plans.

Investigate all Customer Complaints and report results to state or federal agencies as required.

Develop and Review SOPs and IQ, OQ, PQ and all aspects of Validation work.

cGMP Training, new/revised SOP Training.

Facilitator for Safety and QA Committees. Also performed duties as the CBS Safety Officer.

Issue various Monthly Reports to CBS President and Senior Management.

Quality Improvement Report and Incident File Monitor.

Equipment Maintenance/Repair Log Monitor.

Change Control processing and compliance.

SCHERING-PLOUGH CORP (June 2003 – Nov 2003) Kenilworth, NJ

Pharmaceutical Manufacturing Company

Quality Assurance Technical Writer, Warehouse Packaging Operations

I began this Temporary Consulting assignment with Schering-Plough as Q.A. Technical Writer, Warehouse Operations, Kenilworth / Union facilities, reporting to Warehouse Operations Manager. The purpose of my assignment was to review, update, and consolidate Warehouse cGMPs into conformance with Worldwide Quality Standards approved by U.S.F.D.A., in conjunction with 2002 Consent Decree Work Plan. Responsibilities included:

Reviewed individual GMP and determined what revisions were required by comparing actual process performed against written procedure

Reviewed all forms and labels being used against those specified in the GMP, and updated where necessary

Determined if consolidation with other GMPs was possible and drafted consolidated format

Reviewed all proposed revisions in draft format with Management Review Team members, and finalized procedure

Wrote Work Requests for revised/new procedure(s) detailing all necessary changes including Annual Product Reviews

Submitted all Work Request(s) to NJ Technical Documentation Dept. for final composition of procedure

Worked with Tech Docs to obtain final review/approval from required Quality and Regulatory management up to change implementation

Directed Trainer(s) on newly approved GMP so they could implement training for required personnel

REED-LANE, INC., Sampling Dimensions LLC (Oct 1995 – April 2003) Wayne, NJ

Pharmaceutical and Cosmetic Contract Packaging Companies

Quality Assurance Manager

I was hired in 1995 as Quality Control Manager to institute a departmental upgrading to ensure improved cGMP compliance, with all work functions having to comply with FDA, DEA, and customer audit requirements. To enhance this upgrading, I implemented a stronger emphasis on documented training sessions. My responsibilities included:

Supervised approx 24 Q.A. Inspectors and Documentation Specialists

Managed incoming inspection through in-process, as well as finished goods, and reviewed final batch record

Authored company and departmental SOPs

Conducted Supplier Audits, as needed

Monitored the facility to environmental standards

Sampled Retains: testing and storage

Supervised semi-annual internal audits

Organized and supervised Records Maintenance

Developed Documentation Group//Performed IQ, OQ, PQ/Validation Plans

Expanded Calibration Group

Company growth necessitated larger facilities, and in 1999 Reed Lane relocated its 38,000 sq. ft. facility from South Hackensack to a 138,000 sq. ft. facility in Wayne. That same year I was promoted to Quality Assurance Manager. By 2002 the Q.A. Department experienced a greater than 100% expansion, to include 24 individuals. At this point I instituted a more rigorous Team-Structured approach to our responsibilities, which effected over a 50% improvement in Batch Record efficiency. In 2003 new management instituted corporate restructuring and company-wide layoffs due to a business and national economic downturn.

CAREX, Inc. / Div. of Rubbermaid (Sept 1990 – June 1995) Newark, NJ

Medical Device / Home Healthcare Products Manufacturer and Importer

Quality Assurance Manager

I was hired as Quality Control Manager with the initial responsibility to implement a QC / QA Dept. for F.D.A. Classified Medical Devices. Within four months I was promoted to Quality Assurance Manager. My responsibilities included:

Staffed a Q.C. Dept. for company compliance to FDA-GMP requirements, MIL Q 9858A, and 105E for Government Contract work

Developed Q.C. Procedures and authored Carex Q.A. Manual

Documented specifications for all Raw Materials (steel, aluminum, and wood)

Supervised the formal documentation of all Incoming, First Piece, In-Process and Returned Product Inspections

Company growth prompted an increase in Q.A. staffing, at which point I also implemented Raw Material Certifications and Product Testing, both internal and external

Upgraded Product Packaging

Monitored scrap metal and identified areas for Process Improvement

Instituted Calibration techniques, developed Product Instructions, and laid the foundation toward ISO Certification

Conducted Internal Audits and Supplier Audits

Supervised Customer Complaints documentation, and worked with suppliers to upgrade quality issues to eliminate quality deficiencies

Undertook a major project to upgrade the quality of our off-shore suppliers, both Asian and European, by implementing Audits and Failure Analyses on defective returned products. This project yielded dramatic results in that it raised our customers’ quality expectations, thereby having a positive effect on company sales.

By 1992 I had established a well-run Quality Assurance Dept. with five Inspectors reporting directly to me. In 1994 an FDA Audit found the company Quality System to be problem free. During 1993-1994, an IBM computer system was installed in the Q.A. Dept., at which point I became an integral part of the New Product Development Process, trained new Customer Service Representatives, and became a member of the Safety Team. By March 1995 I had nine associates reporting to me. In 1995 Rubbermaid purchased Carex and relocated Healthcare Mfg to Statesville, NC.

LUXO LAMP CORP. / Div. of JJI Industries (May 1984 – Nov 1989) Port Chester, NY

Task Lighting Importer: military, industrial, medical, commercial, office, and cosmetic use

Quality Assurance Manager / OSHA Hazard Communication Compliance Officer

I was hired as Q.C. Manager and in 1987 I was promoted to Quality Assurance Manager / OSHA Hazard Communication Compliance Officer. My responsibilities were as follows:

Structured a Quality Control Department

Initiated programs to comply with required standards, and worked to compliance with U.L. / C.S.A. Standards, D.O.D. / Weapons Systems, ANSI and various Optical Standards

Performed and documented quality inspections

Trained and supervised three inspectors to utilize various types of measuring equipment, i.e., electrical (Simpson meters, Hi Pot testers, Fluke monitors) and mechanical (Calipers, Height gauges, V-blocks)

Worked with Engineers to develop all Product Instructions

Documented Q.C. Procedures and structured and input Part Numbers and B.O.M.s

Contacted suppliers and customers with solutions on how to upgrade and resolve all quality issues

Supervised the proper storage and disposal of our hazardous wastes

J.C. PENNEY COMPANY (Dec 1977 – May 1984) New York, NY

National Retail Distributor, NYC Corporate Offices

Quality Assurance Merchandise Testing Specialist

I was hired in 1977 by J.C. Penney as a Q.A. Product Testing Technician, Merchandise Testing Center, followed by a promotion in 1980 to a

Q.A. Merchandise Testing Specialist, Management Level 6. My responsibilities included:

Quality tested and Reliability tested hard-line Home Improvement, Furniture, Appliances, and Power Tool products

Worked with Buyers to ensure acceptable quality of purchased products

Worked in conjunction with Engineers to ensure that products were assembled/performed correctly, met applicable Safety Requirements

Documented Testing Data/Product Specifications, and prepared Test Reports of my findings and conclusions

ELECTRICAL TESTING LABORATORIES (Dec 1973 – July 1977) New York, NY

Independent Testing Laboratory

Product Test Technician

I began my career as Product Test Technician, Automotive/Mechanical Department. Items tested were architectural glazing materials, refrigerators and freezers, tires and automotive parts/components, and hardware products. Equipment used: Walk-In Chambers, Tensile Compression Machines, meters and dimensional measuring tools. My duties included:

Designed and implemented tests for products, where no previous applicable standards existed

Conducted testing specific to ANSI, AHAM, U.L., DOT, ASHRAE and CPSC Standards

Interpreted Engineering Drawings, recorded Test Data, and reported results back to Engineers

Education

American Society for Quality (A.S.Q.), 2006 Certified Quality Auditor

Blood Systems, Inc., 2016 LSSYB Certified

Community Blood Services, Bergen County, 2004/2005 AABB Training Courses

Union Community College, 1995 Conversational Spanish

American Society for Quality Control, 1995 Certified Quality Auditor Review

Pharmaceutical Quality Institute Services, 1995 Validation Training, National Conference

Juran Institute, 1987 Quality Improvement Manufacturing

Kingsborough Community College, 1984 Computer Technology

N.Y.C. Community College, 1978-1980 Mechanical Technology

Brooklyn Technical High School, 1973 Engineering, Mathematics, Sciences

Professional Member Organizations

ASQ American Society for Quality, Certified Quality Auditor

AABB American Association of Blood Banks

NJSBBP New Jersey Society of Blood Bank Professionals

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