Quality Clinical Research
Resume:
LEON WILLIAMS
Baltimore, Maryland 21207
e-mail: ********@*****.***
SUMMARY: Quality Assurance Professional with over 15 years working with Medical Devices and Pharmaceutical Manufacturing. Strong Background in Science. Strong work experience with Quality Systems for Medical Device and Pharmaceuticals implementing Quality Control Programs and continuous improvement plans. Very strong knowledge of ICH GCP guidelines. Exceptional time management, interpersonal and organizational skills. Strong motivation and commitment. Team oriented focus.
EDUCATION/TRAINING
Bachelor of Science (dual degree), Chemistry and Biology/Lincoln University, Oxford, PA. 1995
GMP: Documentation and Record Keeping
GCP: ICH Good Clinical Practice
Data Management for Clinical Research
PROFESSIONAL EXPERIENCE
XAVUSS RESEARCH, North Ridgeville, OH
Clinical Research Associate(Part-time/Contract) May 2017 – Present
Conducting site initiation, periodic site visits, close out visits and writing reports of findings from site visits(national and international sites)
Conducting remote review of electronic data, identifying and following up on discrepancies, and performing on-site source data verification.
Assisting sites with Regulatory documentation, and ensuring appropriate documents are sent to the sponsor.
MESO SCALE DIAGNOSTICS, GAITHERSBURG, MD. / Medical Device and Diagnostics
Quality Team Lead/Supervisor Nov. '09 – September ‘16
Reason for Leaving: Departmental layoffs.
Devised and implemented production schedules and created compliance processes to ensure quality standards meet.
Lead the planning and forecasting of product development, including: material procurement, personnel scheduling, and administrative responsibilities.
Coordinated human and material resources, including but not limited to: hiring, training, performance reviews of personnel, work scheduling, disciplinary, etc
Monitored product standards (ISO 9001) and implemented quality control programs and continuous improvement plans when appropriate.
Served as a member of the Material Review Board and CAPA Team. Addressed customer complaints and followed through until resolution was reached.
Lead cross functional collaborations as well as proactively addressed potential issues.
T.H. COCHRANE LABORATORIES, WESTMINSTER, MD. /A 3rd Party DOT Inspector of High Pressure Cylinders
Site Quality Manager June ’06 – October '09
Reason for Leaving: Company-wide layoffs.
Responsible for reviewing batch records for completeness and accuracy according to FDA and ISO guidelines.
Trained, supervised and scheduled on-site personnel on company SOPs and GMPs.
Review tests records for accuracy and prepare final results/reports for customers and senior management.
Verified in-coming and outgoing shipments adhere to Code of Federal Regulations 49 part 100 to 185.
Wrote, revised, and established quality standards/guidelines for incoming inspection, shipping and testing procedures.
Conducted internal audits and develop CAPA plans if applicable
Developed, implement and maintain departmental budget.
BD DIAGNOSTICS SYSTEMS. SPARKS, MD / Diagnostics Manufacturer
Senior Quality Formulation Chemist Nov.’04 - May ‘06
Reason For Leaving: Company-wide lay offs.
• Responsible for scheduling the formulation of chemical and biochemical reagents used in
Preparation of diagnostics test kits according to company SOPs and FDA regulations.
Coordinated efforts with several other departments such as: Manufacturing, Compliance, Analytical, Regulatory, Micro, QC testing, and the Warehouse. Also devise flow charts and write/revise SOP’s to optimize synergy and movement of materials between departments.
Performed organic synthesis including protein and oligonucleotide conjugation while optimizing/troubleshooting these organic syntheses.
Lead the purification of crude biotinylated oligos using HPLC. Troubleshoot and perform routine maintenance on equipment. Schedule servicing when applicable.
Lead the initiating and completing process improvement studies to optimize performance. Championed and took part in several Six Sigma projects.
Coordinated and facilitate weekly planning meetings and disseminated daily work schedules for Formulations personnel.
Reviewed batch record documentation to ensure that all formulations adhere/conform to cGMP/QSR/FDA regulations and release/reject reagents and excipients in SAP.
Interviewed and hire new employees. Also write performance reviews and develop IIG’s (Individual Improvement Goals) for subordinates.
PHARMACEUTICS INTERNATIONAL INC, HUNT VALLEY, MARYLAND(3rd Party Biotech/Pharma Manufacturer-one commercial product, all others clinical)
Senior Quality Assurance Associate Sept. ’02-Nov. ‘04
Reason for Leaving: Career Opportunity.
Reviewed and released of all raw materials for manufacturing and packaging.
Supervised Materials Management team (4) for maintenance of accurate records of quarantine materials, released materials, and expiration dates for issuance to batches.
Issued batch records and review upon completion for adherence to cGMPs and SOPs.
Conducted vendor qualification and internal GMP/GLP audits. Prepared and presented audits reports for upper management.
Initiated and/or completed raw material, manufacturing and lab investigations.
Coordinated and Lead MRB (Material Review Board) meetings.
Prepared metrics on raw materials and provided management with monthly reports.
Interfaced with Clients and vendors on QA, GMP, SOP, investigations, expiry/re-test dating, quality issues etc. and resolve any issues.
Revised and/or developed SOP’s relative to vendor processes, auditing and manufacturing of raw materials
Initiated and completed raw material PQE investigations. (Possible Quality Event)
ALPHARMA USPD, BALTIMORE, MARYLAND (Pharmaceutical Manufacturer)
QA Batch Release Team Leader/ Final Release Administrator Jan. ‘01-Aug. ‘02
Reason for Leaving: Career Opportunity.
VTS (Variance Tracking System) and CAPA Administrator-Initiate, Completed and Closed all variances associated with Manufacturing, Production, Raw Materials, etc.
Supervised Batch Release Team(8), including; scheduling, training, etc
Performed internal QA audits and provided corrective action input to upper management.
Performed Batch metrics tracking and presented monthly reports to upper management.
Track all batches from manufacturing conception to consumer sales.
THE PROCTER & GAMBLE COMPANY, HUNT VALLEY, MD (C
Project Manager (Package Development – R&D 1998-2001)
Manufacturing Technician/QA Incoming (1996-1998)
Reason For Leaving: Departmental consolidation/offered but rejected relocation package.
Designed and developed primary and secondary cosmetic packages.
Coordinate die/mold development with outside sources.
Facilitated resin procurement for all cosmetic projects.
Complete validations and DOX on molding tools.
Supervised technicians conducting performance testing for packages
Developed and validated component specifications.
PROFESSIONAL AFFILIATIONS
American Society for Quality
American Chemical Society
Society for Manufacturing Engineers
INSTRUMENTATION AND ANALYSIS LAB SKILLS:
GC/MS, LC, IC, UV/VIS, FTIR, HPLC, Horiba LA-900 Particle Analyzer, PCR, IR, Instron 5500R, Optical Comparitor, HAZMAT training (DOT), GMP/GLP/GCP. Computer Literate: Word, Excel, Powerpoint, Access, SAP, LIMS, JDE.
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