QC Manager

Ronald C. Tucceri, M.S.

**** *********** **.

Kingsport, TN 37664

Home: 423-***-****

Cellular: 423-***-****

E-mail: ttz2ey@r.postjobfree.com

WORK EXPERIENCE

Crown Laboratories 2007 – Present

Quality Control Manager

• Supervised, instructed, and trained a staff on assays, requirements, and protocols in a cGMP laboratory.

• Audited and visited contract laboratories for compliance to company objectives and to cGMP standards.

• Reviewed and approved all documentation for the Quality Control group including, but not limited to, stability reports, investigations, deviations, failures, trends, corrective/preventative actions, company inspection observations, and operational procedures.

• Participated and convened meetings between contract labs, clients, customers, and the company, to ensure timely results.

• Contacted contract laboratories on a daily basis to ascertain the progress on samples and studies.

• Conducted performance appraisals and coached staff in professional development.

• In charge of the stability program for the company including sampling, writing protocols and reports, and updating the databases.

• Hired new employees and addressed personnel issues with HR.

• Ensured that work performed in the laboratory or by contract labs was properly conducted under compendial guidelines (USP, BP, JP, and FDA GMP/GLP).

• Transferred testing of selected raw and finished goods to the company laboratory, as funding was available.

• Developed assays for use in the laboratory.

• Generated all COA’s for bulk and finished goods.

• Organized all laboratory documentation (including submissions, invoices, reports, and results) to be easily searchable upon request.

• Created log systems for chemical receipts, sample acquisition, water sampling, and checking out of stability reports.

• Directly responsible for the monitoring and maintenance of the USP water system.

• Assigned work to staff and reviewed/approved data on a daily basis.

• Held weekly group meetings to update the staff on ongoing projects and goals.

• Conducted operation of the laboratory under cGMP guidelines.

• Provides the senior management with weekly and monthly reports on the laboratory activities both in written form and at all meetings.

• Created and justified yearly budget to senior management.

• Gathered Quotes and submitted requests along with justifications for capital expenditures.

BAE Systems/Ordnance Systems Inc. 2005 - 2007

Manager

Analytical and QC Labs

• Supervised, instructed, and trained a staff of fifteen analysts on assays, requirements, and protocols in the laboratory

• Maintained and prepared a full yearly budget for the operation and staffing of the analytical laboratory group.

• Conducted performance appraisals and coached staff in professional development

• Hired new employees as the need arose.

• Assigned work to staff and reviewed data on a daily basis.

• Held weekly group meetings and weekly safety forums.

• Conducted operation of the laboratory under ISO 9001 and 14001 guidelines.

• Created, updated, and reviewed all methods for use in the laboratory.

• Reviewed specifications for incorporation into the laboratory and gave comments back to governing bodies.

• Developed new log book systems for calibration and usage of instrumentation and equipment.

• Implemented a Laboratory Information Management System (LIMS) for use in the entire facility.

• Initiated a new inventory system for the retention of file and archive samples.

• Installed a First In/First Out (FIFO) system for solvents and chemicals entering the storage area.

• Established Control Charts for the operation of laboratory instrumentation via Minitab .

• Participated in Weekly Sales Planning Meetings and Weekly Production Meetings.

• Coordinated Lean Six Sigma Projects for multiple teams that needed use of the Laboratory Staff and Equipment.

• Completed Lean/Six Sigma Green Belt training and finishing project centering on establishing measurement systems capabilities.

• Responsible for maintaining and troubleshooting all instruments including HPLC, GC, IC, FT-IR, DSC, TGA, Particle Sizing, and XRD.

Wyeth Vaccines 2004 – 2005

Scientist III

Vaccine Technology/Analytical Development

• Supervised and instructed personnel on assays and testing requirements for use in the laboratory following cGMP guidelines.

• Responsible for all new and existing equipment entering the laboratory including calibration and preventative maintenance.

• Established a new analytical laboratory for support of Vaccine Technology’s effort in process improvement.

• Created protocols (SOP’s) and validations for instrumentation used in Vaccine Development.

• Performed all Vaccine testing in compliance with cGMP guidelines as a Quality Control (QC) function.

• Participated in meetings involving process improvements for Vaccine Production.

• Knowledge of 21 CFR 11, 21 CFR 210, and 21 CFR 211.

Becton Dickinson, Inc. 2002 – 2004

Senior Analytical Chemist

Pre-Clinical Safety/Worldwide Medical Toxicology

• Developed extraction methodologies in the pursuit release criteria for medical devices using instrumentation for identification including Agilent HPLC, Agilent GC, TGA/FT-IR, UV/Vis, ICP-OES, and Agilent GC/MS.

• Established protocols (SOP’s), methods, and validations for new products and instrumentation.

• Performed all chemical product safety testing in compliance GLP guidelines, USP guidelines, and with any other applicable international standards (e.g. ISO).

• Developed methods for stability experiments with new sterile drug formulations.

• Tested raw materials and finished products for release.

• Created and implemented long term protocols and project tracking for the development of a new sterile pre-filled medical device.

• Purchased new equipment and service contracts via SAP.

• Wrote technical reports for sponsors and internal usage.

• Interacted with and coached biological department for developing methods for cross training.

• Wrote new spreadsheet applications for calculating outgassing materials for release.

• Knowledge of 21 CFR 58, 21 CFR 211 and 21 CFR 820.

Ansell Healthcare Inc. 1999 – 2002

Analytical Chemist

• Technical supervision of research staff for experimental and professional development.

• Composed and performed procedures pertaining to the gravimetric determination of nonvolatile residues from plastic and rubber materials as well as validation procedures for production. In particular, extractions of the materials with stringent solvents like acetone, isopropanol, and hexane for identification by FT-IR, HPLC, and GC. Compounds of interest included plasticizers, accelerators, cure packages, monomers, and oligomers.

• Developed outgassing strategies of glove materials for GC analysis including low heat and room temperature collection from the packaged and nonpackaged materials.

• Chemical permeation testing of solvents used in the semi-conductor industry as it relates to cleanroom gloves under ASTM guidelines.

• Supervised experimentation in electrical characterizations of anti-static gloves, including resistance measurements, tribocharging, and decay time.

• Performed microscopy examinations of surface features of gloves.

• SEM/EDX characterization of cleanroom gloves and other materials.

• Wrote and implemented a data tracking database for samples, experiments, and requests.

• Over two years of operation experience with the following instruments: IR Reflectance, x-ray fluorescence, x-ray diffraction, Secondary Ion Mass Spectrometry (SIMS), GC/MS, NMR, UV/VIS, AA, ICP-AES, and Ion Mobility Spectrometry (IMS).

PRESENTATIONS

• Caley, D.; Hartkopf, A.; Tucceri, R. Comparison of Tests for Extractable Matter in Cleanroom Gloves. Presented at ESTECH 2001, The 47th Annual Technical Meeting & Exposition of the Institute of Environmental Sciences and Technology. April 22-25, 2001.

• Hartkopf, A.; Tucceri, R. Electrical Resistance and Charged Plate Decay Time of Gloves as a Function of their Water Content and of the Measurement Procedure. Presented at ESTECH 2001, The 47th Annual Technical Meeting & Exposition of the Institute of Environmental Sciences and Technology. April 22-25, 2001.

• Crouso, F.; Hartkopf, A.; Schlatter, N.; Tucceri, R. Strategies for Rating the Chemical Resistance of Gloves Used in Cleanroom Processes. Presented at ESTECH 2001, The 47th Annual Technical Meeting & Exposition of the Institute of Environmental Sciences and Technology. April 22-25, 2001.

• Tucceri, R.C.; Richardson, H.H.; Caldwell, M.L.; Spalding, C.M. SIMS Characterization of Doped and Undoped Aluminum Nitride Films. Presented at The Material Research Society Meeting Spring 1999, April 5-9, 1999, 381.

• Allen, S.C.; Idwasi, P.O.; Tucceri, R.C.; Richardson, H.H. In-Situ Characterization of AlN Growth and Doping Using Emission Spectroscopy. Presented at The Material Research Society Meeting Spring 1999, April 5-9, 1999, 320.

• Tucceri, R.C.; Richardson, H.H.; Harrington, P. de B. SIMS Characterization of III-V Semiconductors. Presented at The Pittsburgh Conference, March 7-12, 1999, 1474.

• Tucceri, R.C.; Rankin, J.G. Principal Component Analysis of Resonance Raman Spectra of Nickel Geoporphyrins. Presented at the XV International Conference on Raman Spectroscopy, Pittsburgh, PA, August 1997, 820-821.

PUBLICATIONS

• Wan, C; Harrington P. de B.; Tucceri, R.C. Proceedings of the 6th International Workshop on Ion Mobility Spectrometry Bastei, Germany, August 10 – 14, 1997 Baumbach, J.I; Stach, J. Ed. 1998, 282-303.

LABORATORY EXPERIENCE

• Analytical Chemist supervising technicians in new test methods for FTIR, GC, HPLC, Laser Particle Counting (LPC), electrical characterization measurements, and general analytical techniques. Wrote tracking database for R&D analytical projects.

• Research Associate Ohio University – III-V semiconductors (synthesis and interpretation) under a DOD/DOE grant. (1998-1999)

• Graduate Research Ohio University (1997-1999)

• Advisor: Hugh H. Richardson

• Graduate Research Marshall University (1995-1997)

• Advisor: J. Graham Rankin

EDUCATION

Post-graduate work Years Attended (1997-1999)

OHIO UNIVERSITY ATHENS, OHIO

Major: Analytical/Physical Chemistry

Advisor: Hugh H. Richardson

Master of Science Years Attended (1995-1997)

MARSHALL UNIVERSITY HUNTINGTON, WEST VIRGINIA

Major: Analytical Chemistry

Advisor: J. Graham Rankin

Bachelor of Science in Chemistry Years Attended (1993-1995)

MARSHALL UNIVERSITY HUNTINGTON, WEST VIRGINIA

Major: A. C. S. Chemistry

Minor: Mathematics

Years Attended (1990-1993)

MARIETTA COLLEGE MARIETTA, OHIO

Major: Chemistry and Mathematics

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