Quality Control Information System
Resume:
Michael Fasanmi
Springdale, Md. 20774
*******@*****.***
Laboratory Skills
Simple inorganic & organic synthesis
Genetic manipulation of plant cell
Cell culturing (animal or plant cells)
Distillation Compound manipulation
Aseptic technique Electron microscopy
Microbiological assays
Light microscopy
Simple and differential staining Preparation and sterilization of media
Pure culture methods Assay of fermentation broths for production Bacterial culture identification
Experience with biophysical assessment techniques for biomolecular characterization and stability evaluation
knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.
GMP experience
Large Scale Purification experience preferred
Education
Morgan State University - Baltimore MD May 2016
Master of Science in Bioinformatics
University of Md. Princess Anne MD May 2011
Bachelor of Science in Biology
Work Experience
AstraZenca- Frederick Maryland
Quality Control information System Analyst August 2024- Present
Perform day-to-day activities and application administration of lab and manufacturing quality control computerized systems.
Support QC lab functions, providing solutions to a variety of technical problems.
1 lab, G-Lims and Empower Software.
Participate in software/computer system validation, IT for software/computer applications and fulfill all networking and security requirements, and global IT for enterprise software applications.
Facilitate and coordinate training of new and existing local admins, prepare training materials as necessary.
Executes protocols, reports, investigations using, and other records, using Veeva on behalf of QC.
Support QC information system lifecycle management activities from concept, development, validation, implementation, maintenance, to retirement.
University of Maryland College Park June 2024 – August 2024
Science Teacher
Provided educational services to incoming high school students to enhance their ability to gain content mastery and to be successful in Biology Physics and Chemistry.
Develops and correlates curriculum and instruction to the PGCPS common core standards within the respective content areas of high school Biology, Physics, and Chemistry.
Utilizes best practices regarding classroom management in order to foster student persistence and success.
PII Pharmaceutical - Baltimore, MD May 2022 - May 2024
Senior QC scientist
Performs tests and analysis of raw materials, bulk and finished products, scale-up samples, process validation samples, cleaning validation samples, and stability samples using a variety of standard and advanced analytical techniques.
Testing in Raw Materials- ROI, LOD, VISCOSITY, TECH WRITER, FT-IR, KARL FISHER and Monitor protocols.
Assists in conducting analytical method validation and method transfer activities, as directed.
Assists in preparing technical documentation including test reports; analytical test procedures; and change controls.
Performed Visual Basic, StatA, TrackWise.
Pre-Study Visit, SIV, and COV for site visit reports to update protocol.
Supports systems to ensure the successful completion of departmental goals and objectives.
Assist users with issues, organize troubleshoot LIMS-related errors and coordinate with the IT team to assist with corrections.
Write and update LIMS, SOPs, and ICH/GCP-Clinical Practice Guidelines
Assists with reviewing and revising laboratory standard operating procedures (SOP) and quality control requirements (QCR)
Assist Metrologist in laboratory equipment qualifications, calibrations and preventative maintenance programs, as needed.
Manages USP reference standards and the qualification of secondary standards, as needed.
Works to ensure compliance with cGMP’s and the site operating procedures under the direction of senior staff or laboratory management.
Executes project plans, schedules, and goals as assigned by the laboratory management.
Performed routine testing such as filter integrity testing, TOC, pH, conductivity and HPLC with EMPOWER data acquisition software.
Familiar with of USP dissolution apparatus 1 and 2 and experience with modified release dosage forms
Knowledge of DEA regulations for the handling of controlled substances.
Conducts equipment audits, conducts some data audits as determined by the Laboratory Quality Assurance/Quality Control Section Manager, and prepares written reports of audits performed
Monitors the laboratory analytical system and data quality of all parameters tested to ensure compliance with the requirements of the Laboratory’s Quality Assurance program
Provides support to the analytical sections by performing calculations, data compilation, and review of initial demonstration of capabilities and method detection limits
Provides support to the analytical sections by performing calibration checks and maintaining supply of thermometers, mechanical pipettes, and weights
Promptly notifies the Laboratory Quality Assurance/Quality Control Section Manager and analysts of deviations detected during any audit or inspection that need immediate corrective action; follows up on deviations and corrective actions
Verifies satisfactory results of corrective actions.
Assists with document control system, including but not limited to, standard operating procedures, maintenance logbooks, extraction logbooks, equipment logbooks, standards and reagents logbooks, chemicals and materials master logbook, standards master logbook, and analytical worksheets.
Assists with inventory and control of internal and external proficiency tests and quality control samples, change controls and CAPAs
Catalent Pharmaceutical - MD June 2020 - December 2022
Quality Scientist Analyst II
Experience with cell based molecular techniques I.E T/cells
Monitor cell cultures for sign of contamination.
Perform routine testing such as filter integrity testing, TOC, pH, conductivity and HPLC.
Experience with ELISA testing.
Perform assays such as qPCR, RT-PCR and ddPCR, ELISA, DNA/RNA extraction, Western Blot, gel electrophoresis, HPLC and Capillary Electrophoresis
Provide instrumentation care, maintenance, troubleshooting, data interpretation, change controls.
Assists with reviewing and revising laboratory standard operating procedures (SOP) and quality control requirements (QCR)
Worked with laboratory investigations, out of specifications (OOS), deviations, & CAPAs),
Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured.
IMV- interim monitoring visit
Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending
Ensures compliance with cGMP and safety requirements within the QC analytical laboratory
Participates and carries out continuous quality improvements in the QC laboratory
Participates in project specific, system, client, and vendor audits
Maintains QC analytical laboratories and facilities in an audit ready status at all times.
Conducts training on applicable SOPs, regulatory requirements and quality initiatives with new recruits.
Strong focus on ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up and ability to make timely and sound decisions (Quality and Business).
Possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management across functional groups.
Review the implementation and efficiency of quality and inspection systems.
Investigate customer complaints and non-conformance issues.
Prepare reports to communicate outcomes of quality activities.
Identify training needs and organize training interventions to meet quality standards.
Evaluate audit findings and implement appropriate corrective actions.
GSK - (GlaxoSmithKline) – Rockville, MD February 2014 - 2019
Pharmaceutical manufacturing Associate / Quality Control
Sample Media from several cultures and samples.
Flush and dispensing WFI & WPU in a microbial production
Working on Media Prep tanks
Worked in a cGMP environment & following SOP.
Dispensing, Fluid air, NIRO Granulation
Cell Culture
Collecting and Entering data using batch form.
Operate tank in SIP-Sterilization in Place.
Participate in Factory Acceptance Test
Perform math calculations required for batch processing
DSM – Columbia, MD Fall 2011 - 2014
Research Associate/ Lab Technologist (Overnight)
Sample Media from several cultures and samples.
Follow lab procedures for handling specimen.
Analyzes specimen based on company approved SOP.
Follow HIPPA, CLIA, OSHA, safety guidelines.
Follow company procedure in reporting results to clients.
Maintain complete records of all testing performed on-site
Collecting and entering data for 3rd and 2nd shift.
Identify problems that may adversely affect test. Performance of test results.
Overnight runs and data analysis of production
Monitor Control of Batch records
Dispensing, Fluid air, NIRO Granulation.
Working on Media Prep tanks
CVS Pharmacy - Bowie Fall 2008 - 2011
Pharmacy Manufacturing Technician
Retrieve, count and measure drugs (except CIIS).
Retrieve and file pharmacy prescriptions in the appropriate files and assist Pharmacist with checking in and pricing drug orders (except CIIS)
Maintain inventory levels of outdated/recalled merchandise.
Worked in a cGMP environment & following SOP
Review adverse drug effects
Assist the Pharmacist with all third-party transactions.
Monthly Data Analysis of rate/sales of CI drugs- Statistical Inferences
Follow HIPPA, CLIA, OSHA, safety guidelines.
Med-Immune Summer 2006 - Fall 2007
Clinical Research Assistant
Preparing all media and cultures
Blood Bank/Plasma
Gather and analyze statistical data for research
Order supplies for department
Inventory check and Supply stock
Monitor Control of Batch records
Data analyst
Web / Domain Services
BLS/CPR Certification
Chess Wizards - Silver Spring, MD December 2015 - April 2016
Chess Instructor
Present lessons to the students that are conducive for proper Chess play
Create organized groups students according to skill strengths
Managed a classroom size of 13-20 students.
Foster greater life skill principles throughout the games
Maintain status of student’s games and present advise when necessary
Skills
Customer Service (8 years)
Microsoft office software (8 years),
Administrative /Program Management (7 years),
Adobe Audition (2years)
Event Assistant (1 year),
Fundraising (2 years)
Sales (5 years)
Certifications/Licenses
CPR- Certification
BLS- Certification
First Aid
First Aid
Contact this candidate