Awad Abuelmaali
Schenectady,NY
Summary
A versatile, highly motivated and detail oriented professional looking for a fulfilling role that provides growth and development opportunities where I can apply my analytical, communications and problem solving abilities to help drive team success and improve Standard operating procedures. 6+ years of combined experience in Pharmaceuticals, Research, Consulting and Project Coordination across various industries including Healthcare industry, and Finance. Experienced in quality assurance to ensure compliance with GMP regulations, guidance documents, SOPs and established company procedures. Experienced in quality control testing and data review including test planning, implementation, documentation update/revision and execution to support manufacturing. Collaborative but decisive personal style and effective communicator and problem solver.
Overview
8
8
years of professional experience
Work History
QUALITY ASSURANCE COORDINATOR- VENDOR QUALITY MANAGEMENT
VERTEX PHARMACEUTICALS
01.2022
- Coordination of lab equipment installation process including procurement approvals - an outline of the steps from requisition to approval to purchase to receipt of goods
- Review / approve qualification and validation documents as needed
- Review of vendor documentation in support of qualification, preventative maintenance, and repair work
- Support change control activities impacting QC equipment; provide impact assessments when required
- Writing and revising control test procedures, SOPs, technical documents, and qualification reports
- Maintaining action logs, approved vendor list (AVL), templates and trackers, and revisions and uploading/routing of SD documents
- Coordinated contracts and agreements; assisted with execution of Purchase Orders (PO)/Requisitions, and conducted follow-up on approvals; distribution of PO; troubleshooting vendor payment issues
- Performed data entry into GxP regulated systems as required
- Managed events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion
- Performed Archival of QA Records in EDMS and files documents to Sharepoint (e.g., vendor records).
QUALITY CONTROL ANALYST II (4+ YEAR)
REGENERON PHARMACEUTICALS
01.2018 - 01.2022
- Extensive experience in writing and reviewing investigations into non-conformances in accordance with cGMP practices and all regulatory and quality requirements
- Extensive experience in analysis and evaluation of information gathered through investigations as well as summarizing information and trends for investigation reports
- Experienced in writing CAPAs/Change Controls and proposed actions to prevent reoccurrences in support of manufacturing operations
- Prepared various investigation reports that include recommendations on investigation findings for medium/high severity non-conformances
- Writing and revising control test procedures, SOPs, technical documents, and qualification reports
- Authored and reviewed numerous primary data sources to assure the accuracy of investigative conclusions in accordance with cGMP standards in support of investigations
- Conducted and facilitated Cross Functional Meetings for investigations in order to ensure all regulatory and quality requirements were met
- Responsible for writing investigations/deviation reports and performing root cause analysis for Atypical, Out-of-Trend, Out-of-Specification test results along with deviations from procedures
- Responsible for training and qualifying analysts on various assays including HPLC, protein analysis, pH, conductivity, and protein concentration for in-Process, Stability and Release samples
- Responsible for performing complex sample preparation and HPLC analysis for In - Process, Stability, and Release samples
- Assisted in implementing Continuous Improvement ideas cross functionally with various groups and departments to increase the efficiency, quality, and safety for commercial testing laboratories
- Conducted meetings with various groups within different departments to effectively reduce human error and increase efficiency of performance
- Schedule monthly technical meeting to help communicate the development of our routine assays and equipment to testing analysts
- Facilitating and supporting cross-site / cross functional continuous improvement projects and structures problem-solving activities working to eliminate waste
- Performed and utilized statistical analyses techniques in order to identify trends and to support investigations.
MEDICAL TRANSCRIPTIONIST (2+ YEARS)
ELLIS HOSPITAL
01.2016 - 01.2018
- Extensive medical transcription experience
- Transcribed reports dictated various hospital staff including physicians, PAs, and nurse practitioners
- Strong knowledge of medical language and transcription practices and guidelines
- Highly oriented in written and numerical detail
- Good general knowledge of human anatomy and physiology.
RESEARCH EXPERIENCE (2 YEARS)
STATE UNIVERSITY OF PLATTSBURGH
01.2014 - 01.2016
- Organic chemistry laboratory research assistant in a Green Chemistry - Deprotection project
- Tasked with Extraction, Rotary evaporator, Filtrations, TLC, Column Chromatography, NMR
- Electrolytic Fuel Cell Research project
- Tasked with Converting chemical energy to electrical energy
- A year and a half long research project that required using various concentration of acids and bases on Fuel cell as well as use of a Potentiostat device to control voltage between electrodes and Impedance Spectroscopy to compare dielectric properties.
Education
BACHELOR OF SCIENCE IN BIOLOGY -
UNIVERSITY AT PLATTSBURGH, SUNY
01.2015
Skills
- Quality Management Systems
- Strategic Planning
- Material Specifications
- Documentation Management
- ISO Standards
- Quality Control Analysis
- Attention to Detail
- Critical Thinking
- Effective Multitasking
- Strong Work Ethic
- Team Collaboration
- QMS
Interests And Skills
Excel in a fast pace environment, Very organized with a keen eye for detail, Excellent at critical thinking and problem solving, Utilize spreadsheets to track and report activities and progress, Excellent at multitasking including prioritize multiple assignments and changing priorities when required, Ability to work independently or collaboratively, Knowledgable and experienced in Microsoft Suite (Word, Excel, PowerPoint), Strong interpersonal skills., Excellent written and verbal communication skills., Javascript. HTML, CSS, Good understanding of biologics manufacturing operations, True
Timeline
QUALITY ASSURANCE COORDINATOR- VENDOR QUALITY MANAGEMENT
VERTEX PHARMACEUTICALS
01.2022
QUALITY CONTROL ANALYST II (4+ YEAR)
REGENERON PHARMACEUTICALS
01.2018 - 01.2022
MEDICAL TRANSCRIPTIONIST (2+ YEARS)
ELLIS HOSPITAL
01.2016 - 01.2018
RESEARCH EXPERIENCE (2 YEARS)
STATE UNIVERSITY OF PLATTSBURGH
01.2014 - 01.2016
BACHELOR OF SCIENCE IN BIOLOGY -
UNIVERSITY AT PLATTSBURGH, SUNY