J.WilliamsResume
2
Jessica Williams [email protected] Profile Extensive cGMP pharmaceutical experience entailing investigational analysis, instrument support, method validation, and technical writing. Familiar with zone gowning and working in production and sampling environments. Zero failure to follow procedure deviations generated during cGMP career. Career Achievements Sandoz Generic Pharmaceuticals – Novartis, Broomfield CO Project Management Successfully planned and implemented a Raman container ID testing pilot program in a zone 2 manufacturing area (2014) Developed and implemented the first Sotax CTS method validation procedure within the global Sandoz network (2014) Constructed and validated 65 Raman container ID testing methods for 76 APIs and 32 excipients (2012 –2014) Completed 91 extraneous matter investigations from 2011 to 2014, 41 of which were completed in 2012 Human Error Statistics 100% of 2014 instrument requalification protocols generated, executed, and completed on time Zero overdue or extended compliance or quality records in 2013 and 2014 (change controls, CAPAs, USP reviews) Generated zero failure to follow procedure deviations during entire career as a full-time employee (2010 – 2014) Career Development Established a management successor role and completed training/mentorship program with direct manager (2014) Received two promotions during five years of employment (2010 – present) Technical Experience & Skills Sandoz Generic Pharmaceuticals – Novartis, Broomfield CO Temporary Chemist – Quality Control, Raw Materials June 2009 – February 2010 Chemist I – Quality Control, Raw Materials March 2010 – May 2011 Chemist II – Quality Control, Raw Materials June 2011 – July 2011 Chemist II – Quality Technical Support, Investigational Analysis August 2011 – November 2012 Chemist III – Quality Technical Support, Investigational Analysis December 2012 – June 2013 Chemist III – Analytical Services, Laboratory Support July 2013 – Present Skill Mastery: Technologies – FTIR (Thermo-Nicolet), Near-IR (Bruker), Raman (Thermo and TruScan), CTS (Sotax) Techniques – Stereomicroscopy, FTIR, IR-Microscope, IR Spectral Analysis and Interpretation, SEM-EDS Sample Preparation, SEM- EDS Spectral and Semi-Quant Interpretation, Clemex Image Analysis Methodologies – FTIR, ATR, UV/Vis, TLC, Particle Size by Horiba, Solvent Based Extractions, Water by KFT and LOD, Manual and Auto Titration, Solution and Reagent Preparation Technical Writing Experience: SOPs, equipment qualification protocols, training documents, business cases, asset requests, investigational reports, validation protocols, general protocols, and quality events Analytical Services, Laboratory Support Customer Service Department Responsible for Laboratory Equipment Support/Purchase/Qualification/Implementation Calibration, PM, maintenance, repair, and qualification of laboratory equipment according to USP, EP, 21CFRPart11, corporate, and site regulations/policies Ownership, execution, and closure of equipment change controls, corrective actions, and effectiveness checks Deployment of robotics program for automated content uniformity testing including training plan development Quality incident reporting, writing, and impact assessing Quality Technical Support, Investigational Analysis Customer Service Department Responsible for Operations Support and Method Development/Validation/Transfer Forensic analysis (isolation/identification) of extraneous matter and microscopic particles by spectroscopy/microscopy to support root cause analysis for deviations, investigations, and customer complaints Development and validation of NIR and Raman identification testing libraries Quality Control, Raw Materials Quality Control Laboratory Responsible for Raw Material, Cleaning Validation, and Finished Product Release Testing API and excipient raw material testing according to USP, EP, BP, and internal methods (primarily wet chemistry) Finished product identification testing according to USP, EP, BP and internal methods
-
Upload
jessie-williams -
Category
Documents
-
view
27 -
download
0
Transcript of J.WilliamsResume
Jessica Williams [email protected]
Profile
Extensive cGMP pharmaceutical experience entailing investigational analysis, instrument support, method validation, and technical writing. Familiar with zone gowning and working in production and sampling environments. Zero failure to follow procedure deviations generated during cGMP career.
Career Achievements
Sandoz Generic Pharmaceuticals – Novartis, Broomfield CO Project Management Successfully planned and implemented a Raman container ID testing pilot program in a zone 2 manufacturing area (2014) Developed and implemented the first Sotax CTS method validation procedure within the global Sandoz network (2014) Constructed and validated 65 Raman container ID testing methods for 76 APIs and 32 excipients (2012 –2014) Completed 91 extraneous matter investigations from 2011 to 2014, 41 of which were completed in 2012
Human Error Statistics 100% of 2014 instrument requalification protocols generated, executed, and completed on time Zero overdue or extended compliance or quality records in 2013 and 2014 (change controls, CAPAs, USP reviews) Generated zero failure to follow procedure deviations during entire career as a full-time employee (2010 – 2014)
Career Development Established a management successor role and completed training/mentorship program with direct manager (2014) Received two promotions during five years of employment (2010 – present)
Technical Experience & Skills
Sandoz Generic Pharmaceuticals – Novartis, Broomfield CO Temporary Chemist – Quality Control, Raw Materials June 2009 – February 2010 Chemist I – Quality Control, Raw Materials March 2010 – May 2011 Chemist II – Quality Control, Raw Materials June 2011 – July 2011 Chemist II – Quality Technical Support, Investigational Analysis August 2011 – November 2012 Chemist III – Quality Technical Support, Investigational Analysis December 2012 – June 2013 Chemist III – Analytical Services, Laboratory Support July 2013 – Present
Skill Mastery: Technologies – FTIR (Thermo-Nicolet), Near-IR (Bruker), Raman (Thermo and TruScan), CTS (Sotax) Techniques – Stereomicroscopy, FTIR, IR-Microscope, IR Spectral Analysis and Interpretation, SEM-EDS Sample Preparation, SEM-EDS Spectral and Semi-Quant Interpretation, Clemex Image Analysis Methodologies – FTIR, ATR, UV/Vis, TLC, Particle Size by Horiba, Solvent Based Extractions, Water by KFT and LOD, Manual and Auto Titration, Solution and Reagent Preparation
Technical Writing Experience: SOPs, equipment qualification protocols, training documents, business cases, asset requests, investigational reports, validation protocols, general protocols, and quality events
Analytical Services, Laboratory Support Customer Service Department Responsible for Laboratory Equipment Support/Purchase/Qualification/Implementation Calibration, PM, maintenance, repair, and qualification of laboratory equipment according to USP, EP, 21CFRPart11,
corporate, and site regulations/policies Ownership, execution, and closure of equipment change controls, corrective actions, and effectiveness checks Deployment of robotics program for automated content uniformity testing including training plan development Quality incident reporting, writing, and impact assessing
Quality Technical Support, Investigational Analysis Customer Service Department Responsible for Operations Support and Method Development/Validation/Transfer Forensic analysis (isolation/identification) of extraneous matter and microscopic particles by spectroscopy/microscopy to
support root cause analysis for deviations, investigations, and customer complaints Development and validation of NIR and Raman identification testing libraries
Quality Control, Raw Materials Quality Control Laboratory Responsible for Raw Material, Cleaning Validation, and Finished Product Release Testing API and excipient raw material testing according to USP, EP, BP, and internal methods (primarily wet chemistry) Finished product identification testing according to USP, EP, BP and internal methods
Jessica Williams [email protected]
Marathon Petroleum Company, Catlettsburg KY Laboratory Technician – Environmental Research and Development October 2008 – April 2009
Development Laboratory Responsible for Water, Soil, Hazardous/Non-Hazardous, and SARA Testing and Method Development Analysis of drinking, surface, and saline water samples for determination of TSS, TDS, and n-hexane extractable material Isolation of semi-volatile organic compounds from aqueous samples using continuous liquid/liquid and manual extraction in
preparation for analysis by GC/MS Routine analysis of performance evaluation samples Determination of method detection limits for EPA method 1664A , SM method 2540C, and SM method 2540D
Professional Credentials
Sandoz Academy, Broomfield CO First Line Leaders & DiSC Management Profile February 2015 Management training course Topics covered: influencing others, coaching for performance, resolving conflict, assessing performance, engaging and
retaining associates, developing self and others, setting priorities Models covered: situational leadership, DiSC profiles, BIR Feedback, GROW coaching, credibility
Hooke College of Applied Sciences, Westmont IL Pharmaceutical Materials and Contaminants (MEI-630) – 3 IACET CEUs September 2011 Particle examination, isolation, and identification by stereomicroscopy, polarized light microscopy (PLM), and FTIR Particle types covered: metals, minerals, fibers, hairs, glass, polymers, chemicals, excipients, and botanicals
Education
Michigan State University, East Lansing MI Bachelor of Chemistry December 2008 GPA: 3.66 on 4.00 scale – Graduated with Honors Honors and Scholarships: Bradford-Adams Scholarship 2007 – 2008, Michigan Competitive Scholarship 2007 – 2008,
Academic Leadership Scholarship 2005, Transfer Scholarship 2004 – 2006, Golden Key International Honor Society 2007 – 2008, Phi Theta Kappa International Honor Society 2005 – 2006
Community Outreach & Service
Big Brothers Big Sisters of Colorado Mentor Spring 2012 – Summer 2014
Sandoz Broomfield Library Project Instructor Fall 2010, Fall 2011
Michigan State University Lead Service Learning Mentor Fall 2006
Grand Ledge Public Schools 5th-8th Grade Girls Volleyball Coach 2005 – 2006 Chemistry and Mathematics Tutor 2004 – 2006
National Honor Society Mentor and Elementary Reading Tutor 2002 – 2004
Programs/Applications
SAP, Trackwise, Labware LIMS, Empower 2, Empower 3, Microsoft Office (Excel, Word, Powerpoint, Outlook)
Portfolio Available Upon Request
