Quality Assurance Customer Service
Resume:
KIMBERLY D JACKSON
ASQ Certified Quality Auditor
**** ******* **., ******, ** 27712
Home: 919-***-**** - Cell: 919-***-****: actgja@r.postjobfree.com
Summary
I am detail-oriented Chemist with expertise in Quality Assurance principal’s and Regulatory/Complience regulations. I am well versed in Regulatory Submissions for government agencies. Applied experience in working with key stakeholders to develop timelines and responsibilities for the submission. I authored and prepared FDA submissions: PMA, PMA-S, Real time review, Device Defect reports, and Annual reports, create submission strategy and authored reports for FDA and other international agencies. Served as a Regulatory representative in project teams, and provided regulatory support (strategy) for new products/therapies and modifications to existing products.Supported regulatory compliance activities for post market vigilance reporting (MDR), and product recalls. Generated regulatory documents including Technical Files, Declarations of Conformity, Certificates to Foreign Government, and Certificates of Origin used for global product registration. Partnered with global and regional marketing teams to develop regulatory and global registration plans. Documented and maintained oral and written communications with global regulatory agencies.
Highlights
Advanced chemical research GLP environment
Regulatory Docunment Author Practiced in automation
Equipment Maintenance Chemstation expert
Data/Peer Review Lab Set-up expert
Safety Control Committee Member Lab maintenance expert
ID and purchase needed equipment Change Control Specialist
Pharmaceutical Technical Complaints and Deviations Trackwise
Set –up and monitor Stability Studies Contract Negotiations for Clinical
Quality Assurance Auditor Regulatory/Compliance Auditor
Vendor Auditing Commissioning and decommissioning of equipment
Experience
Senior QA specialist (Contract)
March 2013 to January 2014
Merck & Co Durham, N C
Authored technical papers and reports.
Interpreted and classified production and quality data for Vaccine production
Maintained operations below a 3% error rate by ensuring strict compliance with established processes.
Analyzed manufacturing data against functional design and expected quality results.
Documented, filed and maintained proper inspection records and quality assurance documents.
Reviewed batch record documents and relevant records for completion and accuracy prior to archiving and
completion.
Conferred with data processing to obtain information on limitations for data processing projects.
Reviewed and provided comments on the adequacy of documents and took necessary steps to cure any
deficiencies.
Reviewed and provided comments on the adequacy of documents and took necessary steps to cure any
deficiencies.
Scientist (Contract)
May 2012 to February 2013
Catalent Pharma Solutions Durham, N C
Performed analytical testing for inhalation products (MDI and DPI)and devices (marketed and NCE)
Development and Validated stability indicating methods for inhalation products
Developed and validate cleaning verification methods for small scale manufacturing
prepared dosage forms for short term stability testing
Authored of various documents including: analytical methods, specifications, stability protocols, COA and technical reports.
Lead Harmonization for equipment onboarding and maintenance.
QC Scientist Lead Analyst (Contract)
October 2011 to February 2012
Tyratech Morrisville, N C
Maintain GC for extensive testing.
Prepared sample for analysis by GC.
Developed and validated methods by GC for the analysis of natural pesticides.
Associate Scientist
March 2002 to June 2010
GlaxoSmithKline Durham, N C
Performed Method development, validation and analytical testing on solid dose and IVD clinical trial materials and new chemical entities Develop and validate methods for clinical trials.
Author documents including:
analytical methods, specifications, stability protocols and Certificates of Analysis, Prepare regulatory documents such as Investigational New Drug Application / Investigational Medical Product Dossier / Clinical Trial Application for submission, IQ/OQ/PQ.
Prepared clinical trials by researching and writing trial plans and protocols. Sett-up and trained sites. Negotiated site contracts and monitored throughout trial period. Reviewed data and prepared report to project team. Investigate and resolved technical problems related to chemistry, manufacturing and controls. Wrote CAPA’s as need and prepared final clinical reports.
Lead user for team in electronic notebook, trainer for all upgrades and enhancements. Lead team on the installation and validation of online TOC for pilot plants.
Team lead for the onboarding of IMS to be used for the purposes of cleaning validation.
Worked on team for the validation and integration of systems such as Electronic Notebook, Atlas, and Chemstore. Authored and executed Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) Protocols Qualification and ran test scripts. Work on global team to achieve the validation and integration of systems. Experienced in authoring Unit test cases, Integration test cases, System test cases and UAT cases. Experience in authoring Unit test cases, Integration test cases, System test cases and UAT cases. Trained new employees in routine testing and continue to guide them into method development and validation. Perform screening, method development and validation for the analysis of cleaning verification sample by Ion San Mobility (IMS) Proficient in writing and performing validation for laboratory computer software and processes. Trained and supervised team of five in support of pilot plant activities. Ensured completion of Periodic Compliance Review and the required corrective actions were addressed. All work done under current GMP and in compliance with 21 CFR part 11. Experienced in the following: Compendia per USP/PhEur, titrimetry, pH, osmolality, Karl Fisher, polarimetry, spectroscopy, Total Organic, dissolution, content assay and impurities analysis by HPLC.
Research Assistant
February 2001 to March 2002
Scientific Staffing GlaxoSmithKline 5 Moore D Durham, N C
Dose Through Use (DTU), cascade impaction on finished inhalation product (MDI and DPI).
Strong separation background.
Gained experience with ATLAS and ENB (electronic notebooks).
Working knowledge of GMP/GLP regulations along with good oral, presentation, and written communication
skills Possess the ability to work well with others as a team in a rapidly changing environment.
Senior QC Associate
March 2000 to May 2001
Covance RTP, N C
Supervised group of four in chemistry and micro laboritories. Tested in-pro Process and release samples manufactured Supervised two Analysts on the weekend shifts in
Quality Control Lab Performed HPLC, UV, SDS Page, LAL, and Amidolytic Assay Maintained and released
cells for seeding Developed, validated and transferred method for the isolation and purification of proteins
Computer literate with strong background in scientific software such as Chemstation, Turbochrome, Kinlab,
UV Win, Quantity One and spreadsheet software like Excel and Lotus.
All aspects of the job operated under cGMP and GLP.
Chemist II
September 1995 to June 1999
Magellan Laboratories Incorporated Research Triangle Park, N C
Managed a group of 6 scientists.
Responsible for filing NDAs in-time by supporting formulation development, method development, method validation, stability studies and routine analysis. Supervised and lead team in developing and validating analytical methods on priority basis. Trained the staff in instrumental SOP's, STP's and System SOP's. Prepared validation protocols and summary reports. Addressed the OOS (Out Of Specifications) Laboratory incidents (Quality impacting as well as Non-impacting) Deviations. Responsible for writing and updating SOP's and analytical test methods.
Developed, validated and analyzed samples placed on stability as per sponsor request Analysis performed included were purity, potency, identification and physical testing. Testing included solid dosage, inhalation suspension and topical. Authored SOPs, methods and technical reports. All methods followed GMP/GLP and were audited by peers and Quality Assurance. Peer reviewed notebooks and performed Quality Assurance audits. Trainer for new employees. Member of Health and Safety team and Lab Lead for Safety Audits. As company expanded I was responsible for setting up new labs for solid dosage and inhalation testing. This included purchase of equipment and getting laboratory environment suitable for testing.
Assistant Manager
February 1986 to December 1995
Tylaur Inc dba Domino's Pizza Durham, N C
Responsible for organizing weekly scheduling. Supervised daily shifts Ordered supplies based on inventory
and predicted sales Forecast sales based on historical data Preformed duties with customer service taking
priority Responsible for training of new employees.
Research Assistant
May 1994 to September 1995
North Carolina Central University Durham, N C
Prepared laboratory for General Chemistry Labs.
Insured proper laboratory techniques and safety protocols were followed.
Assisted professors in the synthesis of organic compounds and the analysis of those compounds through
Nuclear magnetic resonance, Ultra Violet Spectroscopy, Infrared Analysis, and wet chemistry methods.
All aspects of employment followed Good Laboratory Practices.
Laboratory Technician
February 1993 to May 1994
Roche Biomedical February Research Triangle Park, N C
Extracted trace drugs substance from human samples.
Identified substance by solid and liquid phase extractions.
Specific laboratory equipment necessary includes autoclave, rotovac, savant, incubator, and pH meter.
All extraction followed Standard Operating Procedure, which encompassed Good Laboratory Practices.
Physical Science Aid
August 1992 to February 1993
National Institute of Environmental health Science Research Triangle Park, N C
Monitored high hazard areas Maintained MSDS for the Harvard Communication program Conducted
respiratory fit test on employees Conducted radiation surveys All duties followed Standard Operating
Procedure, which encompassed Good Laboratory Practices.
Education
Bachelor of Science: Chemistry
North Carolina Central University Durham, N C
College Transfer Program 919-***-****
Durham Technical Community College Durham, N C
References
Tristian Fairbrother
Catalent Manager
Leslie Whiting
Merck Supervisor
Keyur Joshi
Catalent Supervisor
Randy Harrison
Co-worker from Magellan
Current position with EPA
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