IT Compliance and Change Management Project Manager who creates strategic alliances with organization leaders to effectively align with and support key business initiatives. Builds and retains high performance teams by hiring, developing and motivating skilled professionals.
Skill Highlights
Project management
Leadership/communication skills
Client account management
Budgeting expertise
Negotiations expert
Extensive knowledge of Laboratory and Manufacturing Processes
System administration
Software Development Life Cycle principles (SDLC)
Enterprise platforms
21 CFR Part 11 ComplianceChange management
Policy/program development
Cross-functional team management
Core Accomplishments
Project Management:
Initiated Continuous Improvement in Change Management space which resulted in increased Process Adherence.
Leadership
Served as key contributing member to Leadership team.
Staff Development:
Launched well-received program of professional development courses for all staff.
Mentored and coached employees resulting in a 20% increase in productivity.Quality Assurance
Streamlined QA process to increase efficiency and Process Adherence.
Professional Experience
10/2013 to 08/2015
Technical ManagerCleveland-Cliffs Inc. – Columbus, IN,
Responsible for ensuring validation of computer and automation systems Ensuring compliance to required regulatory requirements.
Change management review for IT Changes as well as Quality Process Improvement management.
Creation of Continuous Improvement and Process Adherence Project Plans.
Maintains Customer Service excellence for HCL at various client sites across the globe.
Utilizes Industry knowledge and expertise to assist with delivery management of GXP and SOX compliant systems and process.
Corporate Customer service for Change Management initiatives and Metrics analysis.
Change Management Project Lead responsible for Implementing Mentoring and Training Program for Quality Assurance initiatives at the Client sites across the Globe.
Review and audit of various Change Requests related to nut not limited to GXP, non-GXP and Sox compliant system such as CSOPS, CDR, ALIGN, EMPOWER, My Learning, PCL, Quality Portal, and eSTARS Technical Manager/IT Compliance and Change Management Project Lead Delivery management of Lab and Metrology services for Pharmaceutical Clients.
04/2013 to 10/2013
Senior Manager/System SpecialistAvalara Inc. – TX, State,
Responsible for the validation of computer and automated systems ensuring compliance to required regulatory requirements.
Maintains systems and processes developed for computer and automation systems validation up to date and compliant by working with Business owners and Department heads.
Technical owner and Senior Manager of all GXP compliant systems and IT Compliance for TrisPharma.
Develop SDLC validation documentation/deliverables as required (e.g.
Reviews and approves all documents prepared by the validation team, other departments and contractors (e.g.
test plans, impact assessments, change controls, etc.) that deal with System Compliance and System changes.
Over sees execution of qualification protocols as required and preparation of reports of executed protocols.
Initiate and implement change control activities in accordance with site procedures for GXP Compliant systems.
Responsible for Risk assessments and Remediation of any system that do not meet GAMP and 21 CFR Part 11 requirements Proactively resolve conflicts between compliance requirements and project/business constraints.
Co-ordinate qualification activities with engineering, construction, validation and commissioning activities.
Give guidance on all activities related to computer and automation system validation.
Through Periodic Review and Quality System review will make recommendations for improvements.
Investigate and trouble-shoot problems which occur and determine solutions for software systems and Quality Systems.
Participate on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups in TrisPharma.
Project management of all Validation Projects and Companywide It Compliance initiatives.
Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology.
Contribute directly to the completion of projects through the management of assigned contract personnel or internal personnel, if applicable.
Documentation and Data retention Compliance audits.
06/2007 to 04/2013
Senior Business Analyst/Systems AdministrationCatalent Pharma Solutions, Inc. – Emeryville, CA,
Senior Business Analyst for all laboratory driven software and hardware.
Project Manager for Computer Validation projects of all server based and standalone systems working with the Business and vendor on budgets scheduling and resources Responsible for the validation of computer and automation systems ensuring compliance to required regulatory requirements.
Tier 1 support for all of Teva USA laboratories systems and temperature monitoring systems and Response Team.
Coordinator for all Altiris tickets for North America Creation of SDLC deliverables and test scripts for compliance with 21 CFR 11 and ISO requirements as well as approval for the same.
Assist with Server backups and Desktop support functions.
Software and laboratory Support to REES Centron SQL, Empower, Labware LIMS, SDMS, ELN SQL LIMS, IDM, OMNIC, Micromertitics, Bruker optics, UVWINLAB, TotalChrom, Open lab and ChemStation Software platforms and servers.
User support and Altiris ticket resolution for data aquisition software.
SDMS, ELN and Vision Publisher lead support analyst.
Enterprise system implementations and support.
Special concentration in Empower support including but not limited to troubleshooting, installation and user account support SQL LIMS and Labware LIMS product support and Administration.
Training of laboratory personnel on software and SOPS.
Production of protocols and training of employees for newly implemented Lab Information Systems.
Setting up of user accounts and data management.
Software and laboratory Support to all Lab Information Systems Software.
Remediation of all non-validated systems and initial installation document processing.
Change Controls for new upgrades and new validated Systems.
In charge of responsibilities with regard to LIS during Plant and facility shutdowns.
Primary LIS Liaison for all of NJ, NY and PA TEVA Pharmaceuticals USA sites to vendors and FDA auditors.
Lead for Empower 3 and Labware LIMS global implementation Project.
03/2007 to 07/2007
ConsultantPar Pharmaceutical – City, STATE,
Software and laboratory Support to Empower, Lotus Notes, Trackwise, and Chemstation Software.
Special concentration in Empower support including but not limited to troubleshooting and user account support.
Backing up of servers for Empower and Updating of Laptop and Desktop Securities.
Trouble shooting and verification of data transfer of Lace 32 boxes, Acquisition servers and instrumentation.
Mapping of network drives and installation of software.
Updating of Windows security, anti-virus and adware programs for all PC's and Laptops.
Troubleshooting of chromatographic and instrumentation problems related to Empower and Chemstation.
Assisted in setting up reports in Crystal report (Trackwise) and Empower.
Desktop Support and Tier 1 support for laboratory systems and hardware.
09/2006 to 03/2007
Analytical R&D Analytical ChemistPfizer Consumer Health Care – City, STATE,
Responsible for review of completed tests and training of all new employees.
Initiation of OOS investigations.
All Raw Material Testing and training of employees on USP,NF ,BP, and EP methods * Communication with third party vendors for scheduled and random repairs of all instrumentation (GCMS,HPLC, Physical testing and weighing) * Creation of Raw Material Specifications and assistance with updating RM methods.
Ordering of supplies as far as chemicals and Instrument maintenance.
Review of specifications, SOP's and Methods set in LIMS and Documentum * Filling out batch records and COA for finished product production as well as working closely with Manufacturing to test Stability and Production samples * Sending out of samples for outside testing.
Documentation review of logbook and analyst testing.
Testing of RM Development samples and setting specifications for incoming Raw materials.
07/2006 to 09/2006
Sr. Critical Care Clinical QC AnalystInstrumentation Laboratories – City, STATE,
QC testing of blood products, standards, cleaning agents and mobile phases for various QC Testing for production and formulation * Microbial content testing of all products as well as environmental studies of equipment used in production and work environment.
Document review for other analyst's work and value assignments for products inserts * Trouble shooting and regular maintenance of all instruments used for testing, including but not limited to instrument calibration, replacing of electrodes, mobile phases, gas take removal, and blood run analysis.
Training of employees * Blood Drawing * Internal audits of Laboratory and Instrument PM and scheduled maintenance.
2005 to 07/2006
Senior ScientistGlaxo Smith Kline – City, STATE,
Responsible for review of completed tests and training of all Junior Chemist and new employees.
Authoring and reviewing SOP's and Methods in Documentum.
Allowing access to authored SOP and or methods in Documentum.
Initiation of OOS investigations and Deviations for department via Trackwise.
Raw Material Testing and training of employees on USP,NF,BP, and EP methods * Communication with third party vendors for scheduled and random repairs for all instrumentation.
Various testing of GMP and GLP samples and products via GC, HPLC, UV, dissolution and various instruments.
Ordering of both clerical supplies and Laboratory supplies.
Validation of Junior and Senior Scientists quality data in LIMS.
Trouble shooting and Maintenance of HPLC, Transfer modules and Dissolution baths.
Concentration in Nicotine, Pseudonephrine, and aspirin based products.
Use of Scientific Journals for research and development purposes Mass Spectrophotometry, SDS Page, Western Blot, gel and capillary, electrophoresis, ELISA, and other protein purification techniques, Microbiology media preparation.
Gram, Iodine and Methylene blue staining and culturing Assistance with Internal audits for both Health and Safety as well as Global Risk assessment.
Use of LMS for training assessments and remediations.
Remedy, Altiris and Track-it for Problem and Change tickets.
MKS and Trackwise.
Education
Expected in 2001
Bachelor of Science: Biology and Chemistry NJCU - Jersey City, NJ GPA:
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