Charles D. Frazier

** ******** ****

Sparta, NJ *7871

Home: 973-***-**** adtxt2@r.postjobfree.com Cell: 973-***-****

SUMMARY

Self-motivated, results focused IT Business/Systems Analyst with expertise in areas of Project Management, Quality and Analytical Research process development. Keen ability to handle multiple projects simultaneously while accomplishing set goals with on-time performance. Dependable and versatile with proven analytical and problem-solving abilities essential to timely and quality end user support. Specific area of knowledge includes compliance regulations and guidelines followed by the Pharmaceutical industry.

TECHNICAL SKILLS

Networks and Operating Systems

Win8 and 10, Novell and NT Networks, Switches, Hubs and NFS

Chromatography Data Systems

Waters Empower3, Open Lab

Software

Microsoft Office Suite Outlook and MS Project, Access, Project Gantt Chart, Arcserve and Waters SDMS Back-up, TrackWise, Epic Star, Labware LIMS, Rees, ProCal, Proveris Sprayview and Velquest

Compliance

Knowledge of the Code of Federal Regulations, GxPs, FDA & EMEA regulations governing validated applications including (21 CFR Parts 11, 58, 210, 211, 820)

Strong knowledge of cGMP’s & cGLP’s

PROFESSIONAL EXPERIENCE

PAR PHARMACEUTICAL – (Strides Pharmaceutical Inc.) March 2013 – Present

Formally ENDO Pharma Inc., Chestnut Ridge, NY

Sr Analyst IT Manufacturing Lab Systems, Lab Systems

Primary responsibility include production and project support for laboratory computer systems, including system administration activities related to user account management, desktop support, instrumentation computer builds, hardware and software troubleshooting, technical support and validation/qualification for new and existing systems.

Instrumentation and software duties include Waters Empower 3 (CDS), Agilent (LC), Malvern Particle Sizers, HP Chemstation, ICALIS/IDIS, OMNIC FTIR, ICP-Mass Spec, Imaging Software, UV/VIS Spectroscopy, LIMS, Proveris Sprayview, Citrix, Environmental Monitoring System and others.

Support and maintain Laboratory application servers, PC workstations and VMWare workstations, Symantec Netbackup and File share maintenance.

Technical support for new software implementations and upgrades.

Oversee Installation Qualifications (IQs), Operational Qualification (OQs), Performance Qualifications (PQs), 21 CFR part 11 testing, and acceptance testing as required:

Computer systems validation guidelines, Data integrity and archiving review.

PERKIN ELMER – ONESOURCE (MERCK), Shelton, CT July 2012 – March 2013

System Validation Analyst, (Contractor) / Laboratory Systems Support – IT

Primary responsibility included coordinating, implementing and maintaining Legacy Client computers on the company Domain. Ensure that all cGMP compliance issues are met.

Successfully deployed, managed and administered Windows 7 Laboratory computers for Product Development and Quality groups.

Assist in the installation of any required components, defrag disks, and back up or imaging of systems prior to deployment, as per Client 's procedures and policies

Conducted pre-converted systems’ inventories, analyzes requirements, and ensure functionality meets business requirements, communicating any exceptions.

Coordinated activities with IT, scientific and Quality teams to ensure minimal disruption to science while maintaining Client Compliance standards.

Support equipment or system validation or qualification aspects deemed by Client to be a risk to compliance, and ensure technical and procedural compliance to ensure equipment/systems are maintained in a qualified state as well as ensuring 21CFR 11 technical and procedural compliance.

Liaison with Client and Perkin Elmer OneSource Corporation to assist in resolving issues as required.

Charles D. Frazier Page two

BRISTOL-MYERS SQUIBB, Hopewell, NJ May 2011 – May 2012

Research System Analyst, (Contractor) / Laboratory Systems Support - IT

Primary responsibility included coordinating, implementing and maintaining analytical instruments in addition SDLC validation, qualification protocols, decommissioning instruments, test scripts, change controls and periodic review that ensure cGMP compliance.

Successfully deployed, managed and administered Laboratory Instrument logbooks for Product Development and Quality groups.

Provided administrative application system and configuration support for numerous systems such as Rees and ProCal.

Developed Test Plans and for the Validation of the systems and assist User Acceptance Matrix Testing and execution.

Developed User Requirements, Risk Assessments, Process Flowcharts, and Workflow Design documents.

Additional responsibilities included support in the design, development and administering of Laboratory Logbooks (ELN), Velquest and Symyx. Writing, Reviewing and approval of SOP’s in Epic Star.

Provided expertise on system capabilities and limitations and effective solutions to overcome system limitations.

Performed User training after implementation of new systems to all applicable new Users.

Completed Training and approval of Technical documents in DCA via electronic signature.

Participated in site Audit both internal and external review.

Audit Preparation and review of site readiness.

Completion of CAPA assignments and resolution in required timeframe.

REGENERON PHARMACEUTICAL, Tarrytown, NY May – Oct 2010

Lab System Engineer, (Contractor) / IT

Handled service and troubleshooting on a variety of automation lab equipment used in Biotech and Pharmaceutical research facilities.

Successfully deployed, managed newly purchased Waters LAC/E32 systems and UPLC equipment during lab transfers and construction.

Led efforts while working with scientific researchers in providing on-going support of the lab-computing environment that demanded uninterrupted service in the state-of-the-art Biomedical research center.

Provided technical expertise for Desktop support as well as the planning of new system requirements during the evaluation, selection and implementation of lab systems related to vendor supplied software packages and instrumentation systems.

TEVA / BARR PHARMACEUTICAL, Pomona, NY / East Hanover, NJ 2001 – 2009

(Formerly Pliva, Inc.)

Sr. Application Analyst, Quality Management / IT

Managed project and completed upgrade of 16 Perkin Elmer Lambda 25 / 40 UV / Vis WinLab Spectrophotometer units across multiple sites (NY, NJ, VA and OH) through all phases of IQ, OQ and PQ in order to achieve similar application versioning for all units. Created test cases, performed testing and completed final summary report.

Participated in new implementation projects and provided system functional and technical analysis.

Successfully deployed and managed four CDS applications in response to system compliance for FDA regulation 21 CFR Part 11certification.

Participated in all levels of validation phase of related new projects and remediation efforts.

Familiarized with and followed Change Management and Incident Management procedures.

Surpassed customer requirements and expectations by successfully completing on-site installations and maintaining system integrity while ensuring compliance with project cost and schedule parameters.

Led support efforts of 150+ HPLC and GC instruments running on Chromatography Data Systems (CDS) Waters Empower and Perkin Elmer TotalChrom software across multiple sites.

Provided systems support of all computer hardware and software for Quality and AR&D groups including installation, networking, configuration and validation of software applications.

Installed and configured standalone instrument workstations, Thin and Full Client PCs as part of laboratory requirements.

Collaborated as a liaison with Quality Management and IT to create solutions to business problems through process efficiencies and automation.

Transferred 40 Quality Control HPLC and GC systems at New Jersey facility running Perkin Elmer TotalChrom chromatography to Waters Chromatography in the required timeframe.

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ABBOTT LABORATORIES, Whippany, NJ 1991 – 2001

(Formerly Knoll Pharmaceuticals)

Sr. LIMS Chemist, Quality Control

Maintained Laboratory Information System (LIMS) and Waters Chromatography systems for the Quality Control department.

Written, reviewed and approved Standard Operating Procedures (SOP’s) for general guidelines and use of applications.

Designed appropriate screens, required laboratory calculations and reports for Quality systems.

Developed specification and protocol dictionaries for Quality and Stability groups.

Evaluated and tested upgrades to software for standalone PCs and Client / Server based applications.

Written, reviewed and approved test scripts as part of system validation.

Execution of approved test scripts for PQ testing.

Improved communication between contractors and customers to streamline all aspects of the program lifecycle.

Served as a liaison for internal groups during negotiations with outside vendors.

Provided Life Cycle support, training and maintenance of the Stability module implementation.

KNOLL PHARMACEUTICAL, Whippany, NJ 1987 – 1991

Sr. Chemist, Quality Control

Quality testing of manufactured pharmaceutical drug products prior to marketing release.

Trained laboratory personnel on (LIMS) and Perkin Elmer Peak Pro Chromatography software.

Ensured efficient sample testing workflow by troubleshooting and solving instrument problems throughout the laboratory.

Reviewed QA batch records for product release from the Quality Control laboratory.

ONYX CHEMICAL COMPANY, Jersey City, NJ 1985 – 1987

Chemist, Quality Control

Classical methods of analysis: Volumetric titrations, Gravimetric analysis, Spectrophotometric analysis, Visible, UV and IR.

EDUCATION

Computer Programming, Airco Computer Learning Center, Paramus, NJ

Honors Graduate, Peer Tutor

BA, Chemistry, Denison University Granville, OH

Honors: C. L. Williams Award

PROFESSIONAL – COMMUNITY MEMBERSHIPS

American Chemical Society (ACS)

Bright Idea Awards Committee

Co-Chair, East Orange Board of Adjustment

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