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Quality Manager

Location:
Edison, New Jersey, 08817, United States
Posted:
August 29, 2018

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Resume:

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CRITICAL SUCCESS IN PROJECT, QUALITY & PRODUCTION MANAGEMENT WITHIN METALLURGICAL PRODUCTION and general construction operations highlighting progressive experience in process, quality, production planning, and general management with an entrepreneurial and ownership outlook.

Education & Professional Development

ISO 9000 Certification

Six Sigma Certification

Solar Energy Certification

ISTANBUL TECHNICAL UNIVERSITY, Istanbul, Turkey

Bachelor of Science – Metallurgical Engineering, 1991

Professional Experience

Immunomedics Inc,Morris Plains, NJ January 2018- Present

Immunomedics is a pharmaceutical company focusing on the development of antibody-drug conjugates for the treatment of cancer

Senior Manufacturing Support Technician,

Cleans and sanitizes Upstream and downstream areas.Decontaminates transferred equipment according to cGMP guidelines,SOPs,and any other pertient policies and controls.

Supports manufacturing readiness through the preparation and staging of materials and equipment utilizing the automated washer and autoclave.

Provides logistical support to stage materials and equipment as needed

Attends and succesfully completes all mandotary cGMP training.

Maintains inventory of clean room garments for gowning.

Requests all necessary components and operating materials in order to ensure daily operations.

Maintains good communication with support departments in order to comply with all manufacturing needs.

Completes all required production documentation in a legible, error-free, and timely manner following good documentation practices.

Ensures a safe work environment is maintained at all times. Brings equipment and facility issues to the attention of supervisor for resolution.

Trains newly hired technicians and assists in cross-training of less experienced technicians

Ensures corrective actions and improvements

Generate and execute CAPA process

Supports Manufacturing team for Root Causes Analysis

Collaborate with QA team to lead Continuous Improvement

Celgene Corporation, Warren, NJ 7th May 2017 – December 20 -2017

Celgene Corporation is an American biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders.

CART manufacturing Associate

Manufacture clinical grade cellular therapeutic products to supply CCT Clinical Program.

Collaborate with members of Cell Process Development, Quality Control, and Quality Assurance to develop cellular therapeutic processes and products.

Execute/implement Clinical Production batch records for the following areas: cell culture, cell harvesting, tissue processing (placenta), and cryopreservation.

Coordinate daily laboratory tasks

Contributes input toward the revision of Standard Operating Procedures (SOPs)

Daily review of batch records

Prepare and maintain cell culture reagents and media

Ensure sufficient laboratory supplies for daily laboratory operations

Follow SOP’s associated with processing of Clinical Grade Cellular Therapeutics.

Responsible for entering processing data into Batch Records

Operation of laboratory processing equipment, including Biosafety Cabinets and Clean Rooms

Maintain a clean and safe work environment in accordance with policies/procedures and OSHA safe practices

Trained in clean room operations and aseptic technique.

LifeCell Corporation, Allergan Company Branchburg, NJ 13th June 2016 – May 2017

LifeCell Corporation, a Kinetic Concepts Inc. Company, develops and markets tissue repair products for use in reconstructive, urogynecologic and orthopedic surgical procedures

Human Tissue Assessment Technician

Performs aseptic tissue processing activities as required.

Records information on batch records, equipment and cleaning logs, and other documents.

Operates heat sealers, biohazard laminar flow hoods, bar code scanning equipment, aspiration shakers, and computers to enter data and generate reports.

Enters data in Oracle files.

Trained in cleanroom operations and aseptic technique.

Packages and stores medical waste as required.

Trained to work with biohazardous material.

Maintains inventory of processing supplies in the cleanroom.

Sanitizes cleanroom facility.

PharMEDium, Dayton, NJ February 2016 – May 2016

Production Technician

Packaging and labeling of finished products in the final containers or staging of raw materials.

Scan label and process production materials according to the Standard Operating Procedures (SOPs).

Stage carts and inspect raw materials for production in accordance with Standard Operating Procedures (SOPs).

Follow proper sanitization and maintains segregation procedures while accurately staging carts.

Complete necessary documents for accountability and traceability of product following Good Documentation Practices (GDPs).

Support compounding and operation flows wherever necessary, including cross-training for backup.

Safely move materials to and from the warehouse, prepare area and clean room.

Maintain appropriate level of security of working area and product.

Organize and maintain work area based on 5S principles.

Perform daily/weekly/monthly cleaning according to SOPs.

MRS Construction, Edison, NJ 2004 – 2015

Start-up general contracting company specializing in home and business/office improvement and remodeling, including bathroom, kitchen, and basement.

THE FEDERAL METAL CO. Bedford, OH 2003-2004

Producer of the full range of copper-based cast alloys and lead-free alloys

Prepares and handles supplied molds to ensure castings meet quality standards.

Prepares molds per procedures.

Loads molds into ovens according to production requirements.

Prepares metal for pouring (degas, chemical additions, etc.).

Pulls molds from ovens and delivers to appropriate pouring location.

Pours metal into molds according to procedures.

Records all information of temperatures and times for pours into computer.

Performs daily verifications on Spectrometer.

Places parts and/or test samples in Spectrometer to certify chemistry.

ERBAK METAL, Istanbul, Turkey 1999 – 2001

$30M producer of custom brass rod and cast ingot products sold and distributed to domestic clients in the home design and automotive industries.

Plant Manager

Recruited to direct staff and operations of the 10,000 square foot TSE-certified facility in the engineering and production of three product lines (cast, extruded, calibrated) in EU and American Standards. Managed five direct and 50 indirect reports in production planning, quality control, engineering, process control, production, raw materials purchasing, cost analysis, shipping, regulatory / environment, and safety operations.

Led a corporate commitment to quality and customer satisfaction. Drove continuous improvements as the quality champion, instilling focus in supervisors and production staff.

Designed and implemented ISO 9000-based quality system using Six Sigma management techniques introducing analysis, performance metrics, and optimized handling to drive consistent increases in quality performance.

Drove a 80% reduction in product defects through institution of quality processes throughout the production lifecycle, from raw materials to shipping and customer support including implementation of quality inspection in the raw materials receiving process.

Achieved a 20% increase in production efficiency while reducing costs and energy consumption through implementation of a continuous production system that equalized melting and solidified speed. Enabled a 30% energy reduction through optimization of charging method.

Reduced workplace accidents to zero through proactive safety focus and implementation of the use of personal protective equipment.

Surpassed environmental regulations through identification and institution of a three-stage (particle, dust & gas, gas) air filter system.

SARBAK METAL AS, Istanbul, Turkey 1996 – 1999

$110M manufacturer of custom brass pressed and calibrated bars, billets, and ingots to customer specifications using automated induction melting and annealing, continuous casting, and extrusion pressing. Sarbak serves and international and domestic customer base from a diverse range of industries.

Quality Assurance Manager

Planned and managed all aspects of the company’s quality assurance program, as member of executive team. Managed two senior engineers, four junior engineers, and 16 supervisors in the direction of quality program supporting production of 2000 tons per month.

Drove a multi-phase quality optimization program, with resulting productivity, quality, sales, and profitability improvements including a 60% sales increase through study, identification, and application of enhanced technology or process solutions, including Six Sigma methodology and implementation of full cycle quality testing.

Instituted and trained staff in equipment use and proper testing procedures for spectrometers, hardness testing machine, computer-controlled metal microscope, tensile stress and breaking tension testing devices.

Piloted integration of ISO9000. Championed company commitment, steered operational readiness, and realized full compliance with all ISO9000 processes. Partnered with university professors and used competitive benchmark to steer full implementation.

Generated a 2x productivity improvement and follow-on 30% labor reduction through direction of charging and casting process refinements.

Created a team of quality contributors through employee facilitation and training in quality systems.

Performed internal and external quality auditing to insure the organizational processes comply with the requirements of ISO 9000 standards as well as customer, regulatory and organization's own requirements.

Ensured the validation process carried out to achieve the highest quality products via design and development.



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