*** ***** **** ** 267-***-****

Newtown PA ***** ac7uj0@r.postjobfree.com

www.linkedin.com/pub/jim-monaghan/1a/883/a6/

Quality Systems Management Specialist

Highly motivated, top performer with 20 plus years of extensive laboratory experience and a proven track record of delivering high quality, accurate results at progressive levels of responsibility.

Professional experience and qualified skill set with cGMP laboratory, cGLP and cGMP knowledge, extensive working knowledge and use of LIMS, instrumental in implementing new LIMS system for company-wide use, with updates to quality management systems and change control.

EDUCATION

•UNIVERSITY OF SCRANTON, Scranton, PA - BS in Pre-Med/Biology and Chemistry Studies,1996

•DELAWARE VALLEY COLLEGE, Doylestown, PA - Organic Chemistry undergraduate,1995

AREAS of EXPERTISE

Leads department meetings, change control, visual basic, updating quality management system, regulatory compliance, organization, meets corporate deadlines, product origin and desktop questionnaires, quality assurance, investigations, method validations, SOPs, personnel training, client communications, handling technical support, instrument maintenance, LIMS, data control charting, chain of sample custody, ISO/FDA/EPA audits, wet lab testing, GC/HPLC/ICP mass spec testing, Gel Permeation Chromatography, reproducibility, traceability, control charting, retain program, labeling, training, employee reviews, stability testing, CAPAs, NCRs, RMAs, Lot release.

TECHNICAL PROFICIENCY

End to end expertise in the operation, maintenance, troubleshooting, and repair of a broad array of equipment, including: Hewlett Packard GC 5890 and 6890, Hewlett Packard MSD 597*-**-**-**. Tekmar LSC 2000 and 3000, Tekmar ALS 2016, Archon Auto Sampler, Encon Purge and Trap Concentrator, Evolution Purge and Trap Concentrator, Centurion Auto Sampler.

PROFESSIONAL EXPERIENCE

Accupac, Mainland, PA

(2018 - present)

LIMS System and Data Integrity Control

•Laboratory Information Management System Labware specialist, working in tandem with multiple locations and departments to maintain constant data integrity and audit control

•Meets FDA, ISO regulations, up to date client specifications, current revisions

•Performed technical review and editing of QMS documents and specifications. Performed technical writing for specifications as needed.

•Responsible for updates to quality management systems and change control.

United Chemical Technologies, Bristol, PA

(2015 - 2018)

Quality Control Laboratory Manager

•Served as point of contact for auditing for FDA, DEA, EPA, and ISO audits as well as client audits.

•Partnered with Quality Systems Manager on quality system audits.

•Performed review, editing, and authoring of quality/QMS documents.

•Responsible for quality initiatives including Corrective Action and Preventative Action, Continuous Improvement, ISO9000, Yearly Audits, Shipping Quality Checklist, Quality Management Systems, and Change Control.

•LIMS: built, implemented and training on new company-wide system, weekly meetings with LABSoft LIMS Company, designed data audit control, quality system updates, traceability, functional data search ability

•Management expertise in, but not limited to, Customer Issues, Corrective Action and Preventative Action, Continuous Improvement, Research and Method Development, ISO9000, Yearly Audits, Quarantine, Sample Retain Program, LIMS, Shipping Quality Checklist, Client Service Requests, Lab Technical Support, Order Lab Supplies and Materials, Change Control, Quality Management System, Inventory, Financial Reports.

•All classes of DEA drugs, EPA pesticides, and general FDA food contaminants, and EPA volatile compounds

•Direct Reports: 3-6 laboratory employees; remote location reports: 15-18 assembly employees

•Lab bench expertise in, but not limited to, Refractive Index, FTIR, APHA/Gardner color, Amine / Chloride / Hydride titration, GC - Purity, Karl Fisher % Moisture content, Brooksfield / Cannon Fenske Viscosity, % Solids, ICP Metals, Stability, Appearance, Reactivity, Product / Raw Material Lot Numbers, Product / Raw Materials Testing, Gas Cylinder, pH / Buffer testing, Sampling Methods, Instrument Calibration, HPLC - Reactivity / Extraction Methods, 8270 Validation GCMS, 96 well plate.

QC Laboratories Inc, Southampton, PA

(1997 - 2014)

Volatile Organics Manager Interim (2004 - 2005)

Senior Volatile Organics Analyst GC/MS (1999 - 2014)

GC Organics Analyst (1998 - 1999)

Organic Preparatory Technician (1997 - 1998)

•Recognized as a top performer and promoted rapidly to positions with increasing levels of responsibility.

•Perform GCMS volatile organic purge and trap analysis on drinking water, waste water, soil, and methanol samples using EPA Methods 524, 624, and 8260.

•Proficient in the operation and usage of all equipment involved in sample analysis.

•Responsible for data entry with use of HP Chemstation, HP Enviro Quant software, LIMS system.

•Maintain, troubleshoot, and problem-solve all of the Organic Department equipment.

•Developed and maintain highly effective professional relationships with personnel in QA, sample custody, and client services.

•Lead training and development of new GCMS laboratory personnel in the usage of laboratory equipment and in laboratory procedures; execute supervisory duties for GCMS Department.

•Extensive LIMS usage and knowledge.

•IDOC studies, Proficiency Testing, Quantitation Levels, EPA, NELAP, MDL studies.

•Corrective and Preventative Action, Data Variance Reporting.

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