Safety Data

Michael F. Marinelli *** Sherman Avenue, Cedar Grove NJ 07009

cell: 201-***-**** * e-mail: *******.*********@***.*** PROFESSIONAL EXPERIENCE:

Triangle Manufacturing, Upper Saddle River, NJ 4/2013-7/2020 Material Handler

• Performed shipping and receiving activities in 5S lean environment adhering to delivery date requirements as well as customer specifications or standard operating procedures.

• Prepared and expedited items for shipping adhering to delivery date requirements and customer specifications or standard company operating procedures regarding documentation, cleaning, individual and/or bulk packaging, and method of shipment.

• Generated, completed, and reviewed all documentation required for shipment, ensured required documentation and obtained approval from PVI/Documentation Review Specialist.

• Performed receiving Product Verification Inspection (PVI) Documentation Review on incoming shipment by verifying product type, count and condition and reviewed all received documents for accuracy and compliance to Purchase Order.

• Upon review failure, identified shortages, segregated damaged or non-conforming material, and informed Production Planner, and ensured assistance as applicable, any non-conformances regarding product or documentation were documented and dispositioned by authorized personnel.

• Ensured inventory accuracy by entering shipping and receiving data into the Infor system on a timely basis as well as performed physical counts of parts as required to substantiate inventory data. Genzyme Biosurgery, A Sanofi Company, Ridgefield, NJ 4/1999 – 8/2012 Distribution Support Specialist

• Processed full range of distribution related transactions within financial and inventory control systems.

• Knowledgeable of the relationships of all system modules.

• Coordinated the distribution of materials for an assigned location in accordance with governing regulations, guidelines and company procedures.

• Maintained daily interaction with Manufacturing, Business Planning, QA, QC and Finance in an inventory control and distribution capacity.

• Coordinated inventory control and cycle count process.

• Generated reports providing status as necessary.

• Provided training to less experienced staff as necessary. Senior Quality Assurance Inspector

• Responsible for the aseptic area status for gels and fluids.

• Perform line clearances for packaging department.

• Perform labeling and packaging line inspections in accordance with specifications and SOPs.

• Performed inspections and re-inspections for packaging department.

• Inspected and released components and raw materials as per SOPs and specifications.

• Maintained raw materials in-process and finished goods in retain areas.

• Responsible for finished products to be released.

• Familiar with and work in compliance with cGMPs, FDA regulations and guidelines. Sandoz/Novartis Pharmaceutical Corporation, East Hanover, NJ 6/1990 - 4/1999 Senior Quality Assurance Staging Technician & Inspector

• Performed physical and chemical tests to sample: Pharmaceutical intermediates, Packaging components, Raw materials, Water systems and Finished packaged goods.

• Proficient on PC operation and specific computer software. Utilized MRP and LIMS computer systems to record, maintain and monitor sampling information. Page 2

• Maintained inventories and responsible for ordering all sampling and safety supplies.

• Maintained safety data and safety equipment records.

• Responsible for training new employees in procedures and techniques.

• Performed environmental monitoring in various facilities utilizing aseptic techniques.

• Tested critical parameters for all roll materials, such as labels, pamphlets, PVC and foil.

• Performed reconciliation and preparation of documentation for all controlled drug disposal.

• Validation Sampling: Responsible for executing crucial tests in sampling product mixes and granulations in Production Operations.

SPECIALTIES: cGMPs, SOPs, FDA regulations, training, inventory control/MFG Pro, cycle count, quality control, safety, Bartender Labeling software, Infor software, sampling, maintain records, generate reports, line inspections, line clearances, aseptic techniques, fluent in Italian. EDUCATION: Columbia Southern University, Orange Beach, AL; 50+ Graduate Credits Madison High School, Madison, NJ

REFERENCES: Furnished upon request

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