As a CQE specializing in medical devices, pharmaceutical drug products, and consumer products in a cGMP environment, I have a good eye for providing quality improvement initiatives by overhauling workflow and process control. My experiences have given me expertise not only in performing investigations and CAPAs but have also provided me with adept knowledge of the Quality Management System, Risk Assessment, Statistical Process Control, and Audit processing. I have fundamental knowledge of various regulating bodies such as USP, EP, JP, and 21 CFR, quality philosophies, process capability, and continuous improvement. My Master of Science, along with my strong technical background, has been essential in managing projects and in developing and meeting milestones.
Licenses
Skill Highlights
:
* ISO 9001 - CFR - Continuous Improvement Techniques
* ISO 13845 - Investigations/CAPAs - Risk Assessment
* cGMP - Six Sigma/LEAN Principles - Control Charts LIMS - Manager Role, AS400/BPCS, Proficient in Microsoft Office (Word, PowerPoint, Excel, Outlook), Bioinformatics Programs (Molecular Dynamics, Molecular Visualization), Linux OS and Mac OS, Change control using Trackwise and SmartDoc and QUMOS, Oracle for procurement.
Professional Experience
Quality Control/Microbiologist II, 04/2015 to Present Bickford Senior Living – Erie, PA,
Drafted protocol and executed hold time study for extending storage time of cleaning validation swab samples in order to increase production output by 20% while increasing efficiency.
Used Six Sigma principles to conduct investigations in the QC and manufacturing departments to identify root cause and implement standardized processes to reduce incident rate.
Performed IQ, OQ, PQ on Biolog Identification system to move laboratory towards automated systems to reduce testing time by 50%.
Reduced waste by 1/3 and increased effectiveness by organizing work space as part of the 6S Improvement Team.
Wrote technical protocols for Quality Operations for batching of products and led improvements of the existing manufacturing processes and increased process capability Conducted internal audits on documentation and SOPs to assure that all testing complied with USP and cGMP guidelines and laboratory was in compliance and audit ready.
Performed suitability evaluations and report findings about assigned pharmaceutical products and raw materials for ANDA submission.
Developed and reevaluated methods for microbial testing, while finding ways to expedite testing with automated instrumentation.
Responsible for reviewing and releasing all raw data generated in Microbiology laboratory used for releasing finished product and batch record.
, 04/2013 to 04/2015 Fp1 Strategies – Missoula, MT,
Supported and executed cleaning validations for qualification of current and new equipment for microbial analysis.
Provided support for technology transfers, new product launches and validation projects by defining specifications for microbial testing.
Aided in streamlining production floor manufacturing to reduce Takt Time and increased effectiveness by reducing waste and eliminating unnecessary steps.
Performed investigations, CAPAs, and provided quality improvement plans for recurring issues on manufacturing floor and laboratory equipment.
Performed internal audits of manufacturing floor and laboratories along, with external facilities, to ensure cGMP and proper protocols were met.
Reviewed and analyzed product complaints by performing laboratory analysis and providing resolutions to Quality Assurance.
Responsible for batch record review and release of finished product ensuring compliance to cGMP and product specification.
Daily use of Laboratory Information Management System, (LIMS) as a LIMS Manager.
Supervised laboratory as SME in Microbiology and trained Junior Microbiologists as a Certified Trainer.
Executed Micro Awareness Training to educate personnel on contamination control/ safety awareness and aided in reducing training gap.
Performed Microbial Limits Testing, Bioburden testing, Gram's Staining, USP Water testing, Environmental Monitoring, and operated Celsis, Biolog, Omnilog.
Research Associate, 08/2012 to 03/2013 Long Island University – City, STATE,
A Novel Inhibitor of Mammalian Triosephosphate Isomerase Found by an In Silico Approach Co-investigator for examining a novel TIM (triosephosphate isomerase) inhibitor using bioinformatics and molecular biology methods.
Co-authored and edited manuscript that was published in International Journal of Medicinal Chemistry.
Developed and performed enzyme assays using Ultraviolet-Visible (UV-Vis) Spectrophotometer.
Cultured HeLa cells using aseptic techniques and performed in vitro testing of suspect inhibitor on HeLa cells.
Performed bioinformatics techniques such as virtual screening and molecular docking (VINA) and molecular dynamics (AMBER, VMD) to discover and study novel lead compound.
Education and Training
Master of Science: Medical Microbiology Biochemistry and Molecular Biology, Expected in September 2012 LONG ISLAND UNIVERSITY - Brooklyn, NY GPA: Medical Microbiology Biochemistry and Molecular Biology
Bachelor of Science: Biology, Expected in January 2011 LONG ISLAND UNIVERISITY - Brooklyn, NY GPA: Biology
Community Service
Interests
Lorraine Marsh and Jessica Claire, "A Novel Inhibitor of Mammalian Triosephosphate Isomerase Found by an In Silico Approach," International Journal of Medicinal Chemistry, vol. 2014, Article ID 469125, 6 pages, 2014. doi:10.1155/2014/469125
*Active vs. Inactive States of the Alpha 1 Adrenergic Receptors
by Claire, Jessica M.S., Long Island University, The Brooklyn Center, 2012, 92 pages; AAT 1521264
Skills
Approach, AS400, aseptic techniques, BPCS, Charts, Chemistry, cleaning validation, Continuous Improvement, documentation, internal audits, IQ, ISO, ISO 9001, laboratory equipment, LIMS, Laboratory Information Management System, Linux OS, Mac OS, manufacturing processes, materials, Excel, Microsoft Office, Outlook, PowerPoint, Word, molecular biology, Novel, OQ, Oracle, organizing, personnel, PQ, processes, procurement, protocols, Quality, quality improvement, Quality Assurance, Risk Assessment, safety, Six Sigma, specification, Trainer, UV, validation, reducing waste
Additional Information
PUBLICATIONS
*Lorraine Marsh and Jessica Claire, "A Novel Inhibitor of Mammalian Triosephosphate Isomerase Found by an In Silico Approach," International Journal of Medicinal Chemistry, vol. 2014, Article ID 469125, 6 pages, 2014. doi:10.1155/2014/469125
*Active vs. Inactive States of the Alpha 1 Adrenergic Receptors
by Claire, Jessica M.S., Long Island University, The Brooklyn Center, 2012, 92 pages; AAT 1521264
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