Quality Control Professional Experience/Analytical chemistry

PROFESSIONAL SUMMARY

Extensive knowledge of all aspects of the FDA codes and regulations

Understanding of USP, PhEur, JP, EP, BP, and other International Pharmaceutical Organizational standards, regulations, and compliances

Extensive familiarity and experience with GMP, GLP, ICH Guidelines, and GCP

Ability to perform various laboratory functions such as FTIR, UV-Vis, Viscometer, physical chemistry analysis, HPLC, other compendial and wet chemistry analysis of raw material

Broad familiarity of EPA and USDA policies pertaining to agricultural product

Very knowledgeable of all CLIA (Clinical Laboratory Improvement Amendments) regulations and guidelines, as well as a CLIA setting and work environment

PROFESSIONAL EXPERIENCE

BASF

Agricultural Chemist II

June 2015-Present

With a focus on analytics, conducted analytical method development and validation under GLP conditions.

Lead and/or assisted in designing and executing analytical procedures as well as the interpretation of laboratory results (Physical chemistry and chromatography).

Conducted both GLP and non-GLP analysis of pesticide, insecticide, and herbicide formulations.

Developed and validated methods for the quantitative analysis of active ingredients and formulation inert.

Utilized existing, and implemented new, analytical technologies towards increasing analytical efficiencies or solving formulation based problems.

Liaise closely with stakeholders from marketing, biology, regulatory, and manufacturing to understand business needs and determine the best development path forward.

Participated in the transfer of methods to manufacturing sites and provide subsequent analytical support to those sites as needed.

Catalent Pharma Solutions

Associate Scientist

May 2014- May 2015

Completed various projects in QCCA (Quality Control and Compendial Analysis) in a GMP regulated environment

Drafted technical documents such as methods or certificates of analysis.

Performed parallel review of laboratory documentation and perform technical review of documents for accuracy, thoroughness and regulatory compliance

Proactively addressed work issues at both an individual level and a team level in order to execute procedures or methods of moderate complexity with high quality

Ability to interpret and operate a variety of instructions furnished in written, oral, diagram, or schedule form, the various instruments included IR, FTIR, Polarimeter, UV-Vis, HPLC.

API, Excipient, Intermediate, Finished Product, and Raw Material Testing Analysis

Proficiency in using analytical equipment such as UV/Vis and Infrared spectrophotometers, automatic titrators, pH potentiometers, dissolution apparatus, HPLC, GC/MS, LC/MS/MS and other techniques as needed.

Responsible for the support of pharmaceutical product development in a range of dosage forms both directly with customers and in collaboration with other Catalent facilities. This included formulation development, structural chemistry, and analytical support.

LabCorp

Medical Technologist

June 2011- May 2014

Performed tests and analyses according to established procedures in a designated technical department in a GCP and GLP setting

Applied detailed application-specific techniques and technologies to help ensure data quality

Utilized various laboratory instruments such as GC/MS, LC/MS, and HPLC

Developed advanced LC/MS methods for characterization of structural properties and help maintain LC/MS systems and troubleshoot problems independently

Performed extraction procedures on various drugs (benzodiazepines, amphetamines, THC, opiates, barbiturates) to standards set forth in SOPs

Extracted confirmation batches efficiently, accurately, and safely using the latest scientific principles; to provide vital support to the Quality Control Department

Familiarity with bio-analytical techniques such as different types of LC separation, SDS-Page, IEF, Fluorescence and other techniques applicable to monitor protein physical and chemical stability

INC Research

Research Associate

August 2010- December 2010

Process, scan, index, route, and maintain files for CRFs, DCFs and data management documents in accordance with SOPs/WIs

Maintained current regulatory documentation according to Essential Document Review Guidelines (EDRG), Trial Master File (TMF)

Utilized designated clinical trial management system to track and process clinical trial information, such as regulatory documents, IRB re-approvals, and protocol amendments.

Created and maintained document repository for all study-related documents; ensure security of documents at all times in accordance with relevant SOPs/WIs.

Maintained the security and compliance of all documents related to on-going projects as well as archived documents in accordance with relevant SOPs/WIs

Experienced with clinical databases such as Clintrials, PharmaReady

Knowledge of, and skill in applying applicable clinical research regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

In depth therapeutic and protocol knowledge as provided in company training

EDUCATION

Campbell University, Buies Creek, NC

B.S. in Clinical Research

January 2005 - December 2010

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