Description
Summary of Qualifications Experienced Pharmaceutical Research and Development Chemist * established a career in the field of Quality assurance auditing, Regulatory compliance, validation, verification, and process improvement * Strong working knowledge of a broad array of US Regulations, (pharmaceutical Research & Development FDA GMP 21 CFR 210 & 211 compliant), (non-clinical toxicology research studies conducted for investigative new pharmaceutical drugs FDA GLP 21 CFR Part 58 compliant, DEA, EPA, OSHA, AAALAC, and USDA) * (FDA HCT/Ps 21 CFR, Part 1270 1271, and CGTPs for human tissues intended for transplantation into patients recipients) * Highly experienced in Executive Operations who has demonstrated the ability to lead diverse teams of professionals to new levels of success * possess fifteen years experience in various regulated bio-pharmaceutical Research and healthcare industries * Expertise in standardizing operations' procedures across diverse cultures in multiple international locations * Skilled in affiliations and on-boarding new processes and lines of service * Experience in working with international partners on developing and implementing operational processes. Career Highlights: Supervise Quality Department staff. Maintain, implement and monitors BTS' Compliance programs for, Document Control, SOP's, Archives, equipment, Safety, facilities, CAPA, BTS's Cold Storage Areas, Personnel Trainings, critical phase inspections, Facilities walkthrough inspections, performing annual internal audits Departments/Programs and assure proper compliance and execution by all BTS staff. Manage cross departmental projects and systems in various areas of BTS such as operations, In Vitro method validations such as uminophenotyping, phagositosis and cell proliferation, In Vivo. Study Directorship, Surgical Support, Marketing, company audits and other as it relates to Quality Matters. Responds to sponsor investigations and queries as the principal point of contact. Development, implementation, and oversight of quality activities in support of GLP activities conducted or monitored by BTS Research. DONOR NETWORK OF ARIZONA - Phoenix, Arizona NONPROFIT ORGAN PROCUREMENT ORGANIZATION & TISSUE BANK FOR THE STATE OF ARIZONA US FDA HCT/Ps 21 CFR, Part 1270 and 1271 compliant Quality Assurance Coordinator Aug 2014 - Jan 2017 Render keen oversight to the area of Human tissue donor chart review. Act as primary liaison with tissue processors. Participate in the technical writing of various reports. Career Highlights: Ability to multi-task with various quality department functions this includes but not limited to Quality assurance audits of raw data documented in hard copy, electronic records, and recorded interviews and questionnaires required by FDA regulated processes involved in organ & tissue donations, identifying non-compliance issues and ensuring no - contraindications to transplantation, therefore authorize safe release for tissue & organ to be used for transplantation into patients recipients. continued 3 Extensive electronic use for the purpose of investigations, reporting, and communications wile maintaining confidentiality. Such as, electronically report positive serology results to company and outside agencies via eFax, report of non-conformance & CAPA to management using Q-Pulse software, direct communications with various agencies via eFax, phone calls and emails. Primary Contact with various governmental agencies, and clients. Direct EMR electronic access to State of Arizona hospitals to review, and investigate for contraindications. EVERSIGHT- Ann Arbor, Michigan NON-PROFIT TISSUE PROCUREMENT ORGANIZATION (US FDA HCT/Ps 21 CFR, Part 1270 and 1271 compliant) Career Highlights: Researched international medical standards & regulations to develop tissue-bank program from ground up, Worked on diverse work teams and met with regulatory ministry of health agencies to meet deadlines, Developed the organization's international standards and operating procedures to serve as a model. Assisted in the building of a facility internationally to serve as a model for attracting international partnerships. Ability to fluently speak five languages developing strong multi-cultural-teams, building trust, and bringing cornea transplant program to other cultures in Africa, Middle-East, and Asia while maintaining confidentiality. Quality audits for Tunisia Ministry of Health in efforts to be accredited by Eye Bank Association of America, Assisted with the communication of organization's business relations with Abu Dhabi's Ministry of Health Representative at the 2012 World Ophthalmology Conference winning the partnership. EVERSIGHT- Ann Arbor, Michigan Quality Improvement Coordinator Sep 2008 - Jul 2010 Actively performed Quality audits for two major organization's ocular-tissue-banks to ensure compliance with organization's Quality programs, FDA HCT/Ps regulations 21 CFR 1271 & EBAA medical standards. Career Highlights: Responsible for two major Illinois sites to authorize ocular-tissue release. QA review include but not limited to donor charts, aseptic area cleaning, tissues processing logbooks, labeling continued 4 records, supplies logs, sterilization records, equipment maintenance logbooks, tissue release history and disposition in electronic databases Midwire, QA monitoring databases, Performed follow-up on various internal & international reports such as adverse reactions, returned tissue, and post-operative reports. Responsible for preparing two sites ready for FDA Regulatory inspections resulting in zero findings. EXPERIMUR - Chicago, Illinois Quality Assurance Auditor Aug 2006 - Aug 2008 Non-clinical GLP-compliant toxicology research studies conducted for investigative new drugs. Career Highlights: Audited raw data integrity and finalized of reports for compliance with protocols, SOP's and in accordance to GLP regulations 21 CFR Part 58, EPA 40 CFR Part 160 and OECD. Performed critical phase inspections, and follow-up on various internal reports. Performed all Experimur's records management to ensure the readiness of records upon inspection. Conducted external audits & wrote audits report. Revised standard operating procedures and trained staff. NANOSPHERE - North Brook, Illinois Production Associate (contract position) Feb 2006 - Jul 2008 DNA production facility for research purposes to optimize the power of nanotechnology Career Highlights: Audit the manufacturing facility for its first FDA inspection. Investigate all archived manufacturing old logbooks related to storage areas of lot release, Equipment, environmental control, and cleaning. Redesigned the logbooks for lot release, storage areas, and temperature monitoring. Revised related standard operating procedures. Trained staff from R&D, QC, and Manufacturing on the revised processes and procedures, Successful FDA inspections with no findings. Career Highlights: Reviewed analytical test Methods validation data required for ANDAs/NDAs submissions in accordance with cGMPs Regulations 21 CFR 210 & 211identifying potential compliance risks elevating areas of non-conformance through more involved audits evaluating Career Highlights: Performed compounding formulation of parenteral solutions and contact studies, able to use various analytical equipments such as water determination in Raw material using Metrohm volumetric Karl Fischer titrator, and analytical balances. Performed test Methods validation studies using Agilent HP1100 HPLC & GC. Determined physical and chemical properties of formulated finished products. Technical writing of Reports for investigations, deviations, test methods validation, & protocols
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