Description
Summary of Qualifications Enthusiastic, self-starter with the ability to present products/ideas persuasively and build rapport. Flexible, multi-tasker with a strong work ethic and ethics and character of the highest caliber. Creative, attentive to the completion of precise tasks and projects. Enjoys taking initiative beyond stated job and is sensitive to needs of others. Qualified professional providing expertise in the laboratory. Supervised and trained personnel. Wrote, edited and reviewed test procedures. Maintained and updated records and documentation. Created databases. Volunteered to work with at risk population, determined to make a difference. More than 15 years managerial and supervisory experience. Possesses superior written and verbal communications skills. Excellent interpersonal and organizational skills. Definitive analytical, problem-solving and trouble-shooting skills. A reliable and efficient team player who is results and detail oriented. Maintains a high level of computer literacy. Qualification Highlights Minister of Children, Youth and Young Adults Responsible for the daily activities of the children, youth and young adult ministries Taught Bible Study and Preached Children's Church Oversight of the youth mentoring programs Provided counseling to at risk and children, youth and young adults in crisis. Senior Technical Writer Technical and Medical Writing background is in Pharmaceuticals having worked in QA, QC, Manufacturing, Production, Regulatory Affairs and Microbiology. As a Technical Writer produced: Technical Publications Cleaning Validation Protocols Standard Operating Procedure (SOPs) Manufacturing Procedures IQ, OQ, PQ Documentation Raw material & Finished Product Monographs Finished Product Specifications and Stability Indicating Test Methods. Medical Writer of product summaries and investigations. * Completed Product Investigations Handled Customer Complaints Authored Finished Product test methods according to the current United States Pharmacopeia and national Formulary (USP-NF). Assistant Manager Document Control Formed Product Review for updating all raw material, finished product & stability monographs in accordance with the USP-NF. Board Responsible for the organization and implementation of a tracking system for the identification, location and monitoring of all in-process documentation. * Supervised a staff of four in the maintenance and upkeep of all company records and documentation. Created a database for identification of all SOP's and Test Procedures to ensure their timely revision and review. * Assisted in the compilation of data for ANDA's, NDA's and IND submissions for the Regulatory Affairs Dept. * Prepared manual and electronic submissions to the FDA. Member of the Training Team, Safety Committee & a Fire Marshall. Research & Development Manager/Quality Control Supervisor * Senior Quality Control Technician/Research & Development Technician * Trained and supervised lab support personnel. * Directed the testing and release of raw materials, finished products and packaging components. Performed per diem testing of potable water for product use to ensure product viability. * Initiated new product research and pilot batch preparation, also initiated research project for in-house micro lab. Scale up of pilot batches to production scale including product re-formulation when necessary. * Responsible for the testing & maintaining of the potable and DI water systems. * Receiving and testing of all raw materials, component packaging & finished product samples to ensure compliance with FDA regulations and guidelines. * Documentation of all product batch reworks and customer complaints with detailed findings and resultant actions. * Prepared manual and electronic submissions to the FDA. Biology Technician/Software Validation Engineer * Performed functional and biological testing of all component hardware to ensure accuracy and reliability for blood coagulation test machines, all models. * Participated in the software validation for all manufactured machines, ensuring each models' ability to handle a strenuous workload without crashing. Professional & Volunteer Experience * Minister of Children, Youth and Young Adults, Greater Centennial A.M.E. Zion Church 2015 - 2016 * Coordinated all activities for the children, youth and young adults. Taught Bible Study and Children's Church and supervised all mentoring programs * Maintenance Support Staff, The YWCA, Yonkers, NY 2013 - 2015 Office Support Specialist, The Greyston Foundation, yonkers, NY, 2013 Office Manager, Coker, Inc., Mount Vernon, New York, 2011 - 2012
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