SUMMARY:

• Production and R&D Laboratory Management Professional with more than 17 years’ experience in Quality Assurance & Quality Control in the Pharmaceutical and Chemical Manufacturing and Packaging Industry.
• Recent interim Site Quality Manager Experience.Motivated, strong, natural leader and relationship builder with excellent team development and interpersonal skills.
• Reputation as a “Change Maker” with strong client/project focus, possessing excellent written and verbal communication skills.
• Sound knowledge of pharmaceutical, chemical and mechanical processes, medical terminology, GLP, GCP, cGMP, EPA, FDA 21 CFR Part 11,210,211,212,820, USP, JAP, EUP and ISO guidelines.
• Proficient in MS Word, MS Excel, PowerPoint, and MS Project, Outlook, Share Point, Oracle, SAP, Agile, Chrome, Chromeleon, Empower, WinLab, ChemStation, LabWare and People Soft.
• Excellent verbal and technical writing communication skills with the ability to follow complex, detailed instructions by maintaining constant attention to detail.
• Promotes positive energy into complex problem solving & trouble - shooting efforts.
• Teaches and leads by example.
• Expert planning, time management, and cost effectiveness skills utilizing cross-training, multi-tasking and elimination of redundancies.
• Fluent in Microsoft Office, Excel, Outlook, Lotus Notes, SAP, Oracle, Agile, Chrome, LabWare, ChemStation and Win Labs programs and operating systems.
• Proficient in hands on mechanical or technical applications with the ability to multi-task in a fast paced production environment.
• Utilization of advanced mathematics and scientific based reasoning skills. Adept in technical writing, process and standard operating procedure development.
• Experienced in international sales, customer service and local customs & protocols for Europe, Japan, China, South America and the Middle East.
• Fluent in English & German with some conversational French, Italian, Spanish, Japanese and Cantonese.

WORK EXPERIENCE:

Confidential, Sparks, Georgia

Supervisor QC Laboratory Operations, Interim Site Quality Manager

Responsibilities:

• Management & Supervision of all Laboratory Operations pertaining to a 24/7 continuous chemical crop protection and insecticide production plant.
• Testing and Release of all incoming Raw Materials & outgoing Finished Goods.
• Strict adherence to all safety policies under a zero incident mindset (ZIM) and Exposure Reduction Program (ERP).
• Direct Supervision of 12 plus, analytical professional staff including, QA Site Manager Interim duties to meet Federally Registered Specification Document Plans.
• Conducts, Management of Change (MOC), Nonconformance-Out of Specification (NCM- OOS), Root Cause Analysis (RCA) and Corrective Action Preventative Action (CAPA) responses. Creation and Implementation of a GLP/GMP Training Program utilizing Go-Pro Digital Video Systems & Intellidox Document Manger Systems.

Confidential, St. Louis, Missouri

Senior Scientist, Validation Engineer, Lab Equipment Team Leader

Responsibilities:

• Responsible for Design, Execution and Implementation of DQ,IQ,OQ and PQ of all Laboratory Instrumentation and Equipment to cGLP/cGMP Standards, meeting EPA and FDA compliance in an Oral Pharmaceutical Production environment.
• Contracted to validate all instruments and methods in response to FDA Audit findings and warning letters.

Confidential, Phoenix, Arizona

Senior Validation Scientist, Deployment Team Leader

Responsibilities:

• Workstation, Instrumentation and Validation Team Leader, 21 CFR part 11, 210,211,212,820 FDA, EPA & DEA compliance Specialist, for Confidential and abroad.
• Supporting Quality Assurance for Injectable Bio-marker efforts in the treatment of abnormal tissues & Cancers.
• Installs, troubleshoots and validation of CPU, GUI, GC, HPLC, TLC and other Laboratory and Medical Devices.

Confidential, Columbia, MO

Senior Scientist, Project Manager

Responsibilities:

• Designs, carries out and performs complex experiments and procedures in accordance with all applicable regulatory requirements as defined by protocol, method and standard operating procedures.
• Utilizes equipment, facilities and personnel to produce sound scientific results in a timely fashion for Confidential Laboratories’ clients.
• Adheres to a schedule according to facility or contracting organization’s timetable and establishes daily and weekly work routines necessary to ensure on time delivery.
• Designs and conducts most procedures independently using laboratory equipment, computer resources and institutional libraries.
• Conducts training of staff on techniques necessary to perform laboratory assignments. Performs data analysis, first level and peer review of data for accuracy and conformity.
• Prepares data and reports of completed projects ensuring auditable quality for publication at completion of contracted work by clients.
• Responsible for the quality and accuracy of the data and reports sent to client under assigned responsibility.

Confidential, Loudon, Tennessee

Quality Control Chemical Laboratory Manager

Responsibilities:

• Management and supervision of 24/7 continual analysis, “in a Biohazard, GLP/GMP, aseptic and sterile on-site laboratory environment,” of multiple batches of our Product (1,3 Propanediol ( Confidential ). ( Confidential ) is derived from corn sugars utilizing a “genetically modified organism” (GMO).
• Lastly, complete sterilization, separation and refinement to a purity level of 99.9%.
• Sampling at key points throughout the 40 hour per batch, process are tested for: Color, Haze, UV, pH, Conductivity, Oxidation Reduction Potential, Trace Metals, Organic Acids, Sugars, Total Nitrogen and Moisture.
• Utilizing analytical instrumentation such as: Agilent Waters’ gas & liquid chromatography, YSI dextrometer, Agilent UV/VIS, Antek total N2, Karl Fisher water, pH-Conductivity-ORP Meters, Perkin Elmer ICP-AES trace metals.
• Finally, real time adjustments are made to the process by engineers, solely based on the data provided by the QC/QA Chemist.

Confidential, Knoxville, Tennessee

Technical Applications & Training Specialist

Responsibilities:

• Installation & Qualification of Confidential latest cyclotron radioactive isotope delivery systems as well as Confidential many chemistry modules for the production of biomarker, pharmaceutical compounds.
• Responsible for the technical writing of quality control testing, application training, standard operating procedures and safety guidelines as a member on the cyclotron research & development team.
• Provided Customer, Technical Training services for Confidential, at hospital & university clinics to include Asia, Africa, Europe, North, Central & South Americas, as well as the Middle East.

Confidential, Knoxville, Tennessee

Laboratory Supervisor

Responsibilities:

• Seven plus years experience in laboratory management & supervision of analytical professionals engaged in performing chemical and physical analysis supporting qualitative analytical results.
• Responsible for coordination of over 100 daily customer “request for analysis” (RFA) with technical teams in the highly competitive GLP/GMP arena.
• Experienced in managing diverse groups, developing relationships across departmental lines while maintaining open communication with employees at all levels.
• Significant expertise in developing robust test methods, SOPs and instrument protocols in the pursuit of meeting the ever-changing requirements of national & international regulatory agencies.
• Responsible for daily review and validation of all Metals Laboratory results for strict adherence to specifications, policies and procedures.

Confidential, Knoxville, Tennessee

Metals Lab Chemist

Responsibilities:

• Eleven years experience in Elemental Analytical Technology. Performed elemental analysis on a wide variety of sample media utilizing dissolution chemistry techniques followed by quantitative analysis on spectroscopy instrumentation
• Instantly promoted to a group leader role as it pertained to sample status, instrument maintenance and estimated completion dates.
• Created and implemented a laboratory wide safety audit system while supporting laboratory management as safety auditor, chemical spill reaction team leader, First Responder team leader and American Red Cross instructor.
• Served as member of the Laboratory Safety Council.