Quality Control Field Service
Resume:
Todd N. Fite
Carthage, NC ****7
910-***-**** - cell
*********@*****.***
SYNOPSIS
Numerous years of experience in analytical chemistry. Current focus in the field service of pharmaceutical testing equipment, new and existing equipment and instrumentation. Adept in environmental chemistry technique; ranging from extraction to analysis of a variety of sample matrices and testing methods. Responsibilities include testing of finished intravenous, solid dose products, inhalation product testing, analytical method development & validation and GMP and GLP compliance for analytical testing, stability, and manufacturing. Experience in a wide variety of analytical technique; chromatographic and spectroscopic. Thriving and excelling in a fast paced, high throughput environment, continually welcoming new challenges and skills.
EMPLOYMENT
06/22 to present: Catalent (SRG), Morrisville, NC
Senior Associate Chemist, QCCA
Analytical testing of routine and non-routine finished products, raw materials and intermediates by GC, GC-FID and HPLC.
10/21 to 06/22: Seqirus (Artech), Holly Springs, NC
Quality Control Analyst
Responsible method validation by analytical testing of routine and non-routine finished products, raw materials and intermediates for validation within QC laboratory.
10/19 to 10/21: Grifols, Clayton, NC
Chemist, Quality Control
Analytical testing of routine and non-routine finished products, raw materials and intermediates.
08/18 to 07/19: CSA Service Solutions
Field Service Engineer III
Protocol execution, validation and repair of equipment and instrumentation at various client facilities throughout US
IQ/OQ/PQ of equipment via temperature mapping
Agilent trained for Helium Leak Detector PM and repair.
Troubleshooting, maintenance and documentation of work performed.
Visit client sites for PM’s, annual calibrations and repair.
04/15 to 08/18: GSK, Zebulon, NC
Bench Chemist II, Quality Control
Part of method transfer team of Trelegy from UK to US production
Routine and validation testing of Inhalation products analysis by HPLC using Empower software.
02/13 to 02/15: Hospira (Kelly Services), Rocky Mount, NC
Senior CQ Analyst, Chemical Quality
Responsible for analytical testing of Chemical Quality products; in process, final product and investigational testing.
Testing included; HPLC, GC and wet chemistry testing, interpretation, write-up and reporting in LIMS using Empower Troubleshooting instrumentation errors, maintenance and investigation of atypical/OOS results.
Serving as senior by mentoring, training of new and inexperienced analysts.
Serve as analytical & technical resource/mentor to coworkers and client.
01/11 to 09/12: Biogen Idec (Fountain Group), Morrisville, NC
Associate, Sample Control
Sample pickup, transport, documentation in LIMS and delivery; maintain sample chain of custody and tracking of samples
Responsible for aseptically aliquoting of manufactured drug substance for analytical testing and stability protocols.
10/09 to 11/10: QualPak LLC. Laurinburg, NC a division of GOJO Industries
QC Chemist III / Supervisor, Quality Control
Supervise and manage day to day operations of laboratories and corresponding personnel.
Responsible for all analytical work for plant, incoming raw materials, components, bulk and finished goods.
Maintain pharmaceutical grade water quality and integrity by aseptic sampling, plating, incubating/reading of plate results.
Analyzing conductivity and maintaining/calibration of Sievers In-line TOC meter.
Responsible for organization and prioritizing of workload to make most efficient use of time and resources.
Ensure that project timelines and production schedules are met while maintaining product integrity and quality.
Maintain instrumentation compliance; daily calibration, maintenance, tuning, analysis of samples, responsible for scheduling outside vendor visits for PM’s and yearly calibrations.
Writing/review of Standard Operating Procedures and management of projects.
Qualification and certification of current and new laboratory instruments and equipment.
Execution of cleaning validation protocols, inspections and sampling per prescribed protocols.
10/08 to 10/09: Compu Chem Environmental, Cary, NC
Analyst II, Semi-volatile Organics Laboratory
Analysis of semi-volatile compounds by GC/MS.
Organizing and prioritizing workload to make most efficient use of time and resources.
Writing/improvement of Standard Operating Procedures and management of projects.
Evaluation and generation of data from the analysis of various matrices of samples, primarily water and soil adhering
to Standard Test Methods and SOPs established by the EPA and various state agencies.
Development and optimization of existing practices and procedures and trending of testing results.
Qualification and certification of current and new laboratory instruments and equipment.
11/02 to 4/08: GSK / PPD Development, RTP, N.C. / Madison, WI
Senior Scientist, Inhalation Products
Responsible for the analysis and investigation of MDI extractable/leachable project in the Inhalation group at GSK in RTP.
Responsible for the analysis of investigational products and chemical entities of the R&D Inhalation Group at a GSK site.
Testing and method validation of prospective and current inhalation products by ACI, NGI, impurities, content uniformity.
Analysis of compounds by MARS microwave extractor, HPLC and GC/FID analysis.
Analysis of compounds by dissolution (apparatus types 1, 2 & 4), Anderson Cascade Impactors, HPLC, content uniformity, assay, and impurity methods.
Provide support, training and guidance to less experienced coworkers.
QC review of results and data, investigation of irregular/OOS results of other analysts.
Responsible for maintenance, troubleshooting and repair of instrumentation.
Working on group and solo projects simultaneously.
Process improvement, quality and efficiency of workflow.
03/00 to 11/02: Compu Chem Environmental, Cary, NC
Analyst II, Volatile Organics Laboratory
Analysis of volatile compounds by GC/MS.
Organizing and prioritizing workload to make most efficient use of time and resources.
Ensure that project timelines and production schedules are met and sample integrity maintained.
Maintain instrumentation compliance by daily maintenance, tuning, and running of samples.
Writing/improvement of Standard Operating Procedures and management of projects.
Responsible for safety, quality, and training of new analysts.
Evaluation and generation of data from the analysis of various matrices of samples, primarily water and soil adhering to
Standard Test Methods and SOPs established by the EPA and state agencies.
Development and optimization of existing practices and procedures and trending of testing results.
Qualification and certification of current and new laboratory instruments and equipment.
Provide analytical support to areas within the operational site.
09/99 to 03/00: Vintage Pharmaceuticals, Charlotte, N.C.
Chemist
Analysis of solid dosage pharmaceutical products for finished product for release, stability evaluation and quality control.
Analytical methods used were standard for release and stability
Methods include the following instrumentation; HPLC, UV-Vis, GC and NMR.
Coordination of assignments, data review and evaluation for maximum efficiency.
03/99 to 09/99: Life Industries, Charleston, S.C.
Plant Chemist
Conduct research, analysis, synthesis and experimentation on substances for product/process development and
application
Quantitative and qualitative analysis/improvement of analytical methodologies on current products.
Develop formulations, processes and solutions for technical problems.
Conduct experiments and research to develop new products and improve existing product line.
Laboratory management consisting of monitor production and conduct experiments and analysis to assure quality.
Respond to customer inquiries and problems with products and applications.
02/97 to 09/98: Trident Labs, Ladson, S.C.
Lab Manager
Responsible for management of personnel issues, quality of work assignments, daily operations, staffing, employee
training, and new equipment acquisition.
Responding to client questions and analytical needs, giving priority, organizing and assigning lab work
Authorize purchase and order of standards, materials and equipment.
Responsible for safety, quality and scientific aspects; technical services support and customer concerns.
Maintain certifications, clients and secure potential clients business.
Extraction, analysis and reporting of data from organic samples received.
Equipment calibration and maintenance (both preventative and troubleshooting) and daily operation.
Development of new methods by GC and GC/MS to meet client particular needs.
02/93 to 02/97: General Engineering Labs, Charleston, S.C.
Analyst II, Semi Volatile/Volatile Lab
Analysis of volatiles/semi-volatiles and special projects by GC/MS.
Instrument maintenance, tuning analysis trouble shooting and cleaning.
Responsible for preparation of stock solutions, calibration points and continuing calibration solutions.
Organization of sample load for maximum use of time and resources.
Close contact with project managers for consultation concerning sample analysis and data interpretation.
Method development for analysis of organotin and dioxin samples.
Extraction of organics: semi-volatile, dioxin and organotin samples for analysis by GC/MS.
On-site set up of lab and analysis for volatile compounds by GC and GC/MS coupled with a LEAP headspace
autosampler.
09/89 to 02/93: Triangle Labs, RTP, N.C.
GC/MS Analyst/Bench Chemist
Analysis of volatiles/semi-volatiles by GC/MS.
Instrument tuning, daily calibration, inspection of samples, instrument maintenance both daily and extensive.
Organizing, preparation, analyzing and processing of sample load through final data for reporting.
Preparation of standard stocks, working stocks, calibration points for both organic and dioxin departments.
Sample preparation, extraction and clean up techniques employed in wet lab.
Management of support materials and reagents necessary to implement projects.
EDUCATION
Bachelor of Arts in Chemistry – 1992 - University of North Carolina at Chapel Hill
PROFESSIONAL DEVELOPMENT/TRAINING
HazMat Training /DOT Hazardous Waste Handling and Disposal Training Hewlett Packard HPLC Techniques course
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