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Skills

QA/QC Chemistry Analysis
  Agilent Capillary Electrophoresis, Shimadzu HPLC, Waters UPLC/MS, GC, Karl Fisher, Conductivity meters, Instrumentation Laboratories Flame Photometer, Spectrophotometer, Refractometer, TOC Sievers Analyzer, Versamax 96 well, microplate reader, Beckman Densitometer, Buchi distillation unit, Titrino, Bechman FTIR, Perkin Elmer Gas Chromatograph, Perkin Elmer Autosampler, Helena Electrophoresis System, Limulus Amebocyte Lysate endotoxin testing, Hepatitis Antigen/Antibody Test Kits, Ouchterlony ID gel diffusion, reagent formulations, depyrogenation, instrument validation, standard qualification, protocol development, product stability testing, QIAmp DNA kits, microscopes, moisture meters, pycnometer, centrifuges, heating mantles, laminar flow hoods, autoclaves, process inspection, Chemstation Software, Empower 1 and 2 Software, ISO 9001 quality auditing training.
Shimadzu Nexera i UHPLC

Training

Laboratory Safety Certification, Dec 1999; CGMP, GLP, GDP, QLP training; FDA Regulation, USP training, EHS2002 ORA University Courses:Fire Prevention, Expected Conduct of FDA Personnel, Essentials of an Effective Calibration Program, FDA 483's: Inspectional Observations, FDA Tour, Validation Process, FDA Establishment Inspection; FDA Information Security Awareness CourseNIH Ethics Training; FDA Consumer Safety Officer training: Verbal Judo: The Art of Gentle Persuasion and Situational Planning2004: Fundamentals of Spectroscopy (FT-IR, Particle Size Analysis, Atomic Absorption, and UV Vis); PTI-international SOP writing for GMP environment; LIMS automated laboratory training. 2007 to Present:Waters UPLC/MS Training, Waters HPLC and UPLC training, Quality Laboratory Ethics and Data Integrity Training, BioPharma Institute: Good Laboratory Practices Certification, Waters Corp. HPLC to UPLC Method Transfer, 21 CFR 11, 21 CFR 210, World Taekwondo Federation Taekwondo Black Belt; Fred Pryor Seminars, How to Supervise People, and Managing Conflict and Confrontation.

Work experience

Dec 2016Present

Sr. Analytical Chemist/Laboratory Manager

Avella Specialty Pharmacy

*Responsible for developing and overseeing small molecule analytical chemistry laboratory.

*Oversees laboratory construction and setup operations.

*Develops and validates laboratory UHPLC-UV, HPLC-ELSD, and Ion Chromatography methods.

*Performs chemical analyses independently, as part of team, and supervises laboratory employees in carrying out chemical analyses per cGMP guidelines.

*Interprets analytical data, details findings and provides relevant data to support conclusions.

*Presents results orally, written, and in presentation format.

*Reviews current technical literature, researching and recommending to the Quality Manager new analytical procedures and/or equipment.

*Trains, supervises and coordinates the work of laboratory employees on projects.

*Adheres to and promotes all company initiatives related to safety and quality.

*Writes, reviews and updates Standard Operating Procedures *Responsible for Maintenance of Laboratory Notebooks

*Provides support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits

09/201512/2016

Quality Assurance Manager

Celltex Therapeutics

Responsibilities

# Review and improve quality system documentation; write and/or review Quality Assurance (QA) standard operating procedures to assess cGMP compliance on issues relating to sterile biologics manufacturing

# Perform audits of manufacturing and quality control practices and procedures, including internal audits, vendor qualification audits, and audits of investigator sites

# Supervise the QA Specialist on audit-related work, during final production and quality control record review, and during the release of finished products

# Lead inspection and accreditation procedures as necessary, including leading and overseeing audit/inspection preparation activities and remediation plans

# Conduct weekly quality review meetings and prepare reports

# Develop and conduct GXP and safety training courses for all staff annually, post-audits, and as necessary, and maintain staff GMP training records

# Develop budgets and monitor expenditures related to Quality Assurance activities and programs

# Manage recalls and returned products

# Manage the document control system, including document issuance and retirement, and maintenance of document history files

# Evaluate the adequacy and effectiveness of corrective and preventive action plans

# Prepare, organize, track, and perform QA review of FDA submissions to include: INDs, Annual Reports, Supplements, etc.

# Provide interpretation of GMP/GTP/GCP regulatory requirements as they apply to Celltex

Accomplishments

Improved SOPs Prepared the company for third party audits Organized SDS Equipment Calibrations Process Validations Clinical Study Documentation

Aug 2013Sep 2015

Quality and Chemistry Manager

Control Solutions, Inc.

•Reviews all product formulations sheets for adherence to the CSF. Responsible for process improvements. Suggests product improvements that could improve product performance.

•Helps develop the Quality program at the CSI facility and associated facilities. Develops written procedures for production operation in order to manage product quality. Helps with written blending instructions to assure product consistency. Develops methods to improve the grind processing or batch blend.

•Develop analytical methods for analyzing CSI products to assure quality meets product label claims. Works with Global Procurement Manager and Purchasing Manage to source ingredients for NPD. Supports Outside Operations Manager and Global Procurement Manager with outside Tolling centers.

•Works with Regulatory group on required record keeping. Supports new product development - formulations.

•Maintains storage stability for product development and production retains.

Jun 2007Jul 2013

End Product Assurance Laboratory Supervisor

Pharmedium Healthcare

In charge of end product assurance laboratory for an admixture company.

  • Schedule samples for analysis

  • Organize the receiving, storing and logging in of samples from the clean room

  • Participate in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits

  • Review and approve data generated by other chemist

  • Maintenance of Laboratory Notebooks

  • Follow/Generate/Update SOP's

  • Coordinate Instrument maintenance

  • Order supplies and other materials as necessary

  • Coordinate Method Transfers, Method Validations

  • Write and execute protocols

  • Understand OOS/Investigative reports

  • Develop Quality Reports

  • Train QC Chemists

In charge of end product assurance laboratory for an admixture company. Performs Capillary Electrophoresis and UPLC/MS. In charge of releasing capillary electrophoresis, identity, and potency test results. Performs training and development activities for staff. Provide reports to management regarding site QA activities. As required, conduct in-process inspections, facility inspections along with the auditing of data and reports. Investigates quality issues and makes recommendations based lab experiments and process investigations. Maintains laboratory, guides chemists, and writes procedures. Currently improving method development and validation of UPLC/MS testing. Received company award for enhancing the customer experience through improving quality processes and service commitments.

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Dec 2006Jun 2007

Shift Chemist

Kaneka Nutrients

Performed analysis of yeast by use of microbiology, titrations, HPLC, and GC. Audited contract microbiology facilities. Wrote, revised, and followed SOPs. Performed raw materials and intermediate formulation testing. Used Chemstation as well as Empower in processing chromatography. Used LIMS to disseminate test results to management.

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Aug 2006Dec 2006

Night Quality Manager (Temporary)

Biotics Research Corporation

Responsible for monitoring, controlling and reporting the production activities of the second shift operations. Ensured that staff were adequately trained and equipped to perform assigned tasks Coordinated with Quality Control, Receiving, Maintenance and other departments working in production areas to assure efficient operations and product quality. Maintained strict adherence to standard operating procedures at all times. Ensure implementation and adherence to health & safety procedures + all SOPs. Performed facility walkthroughs to ensure high standards of cleanliness and order in all production areas. Prepared and generated daily production reports. Led, motivated and coordinated all employees engaged in the batching and processing phase of dietary ingredients, dietary supplements, food and beverage manufacturing to support production goals and objectives. Updated technical documents (e.g., manufacturing batch records, rework procedures, deviations, etc.) and ensured products met or exceeded Company objectives and customer requirements.

Sep 2005Jun 2006

Quality Associate Scientist

Introgen Therapeutics

Performing analytical testing on cancer cells to assess the efficacy of tumor-suppressing drugs. Follow, write, and revise test procedures in keeping with FDA/ cGMP standards and regulations. Perform qualification testing for validation projects. Shipment of samples to clients. Tests performed include bioburden testing, plaque assay, cytopathic effect testing, restriction enzyme mapping, DNA extraction, biochemistry assays, UV Vis spectrophotometry, HPLC, electrophoresis, and tissue culture manipulation and maintenance. Perform as lead analyst to 4 analysts. Cell culture of HEK293. Performed transfections and 96well plate ELISA tests.

Sep 2003Sep 2005

QC Scientist

Wyeth Vaccines

Used LIMS to evaluate raw materials, intermediates and finished products to meet specifications. Recorded and maintained data obtained through testing. Followed proper testing protocols and SOPs for chemical analysis with proper documentation. Tested in preparation for new product development, production, process improvement, stability and validation. Performed analytical confirmations. Planned activities to meet testing needs, assess support requirements and establish priorities. Communicated day to day activities status update, both oral and written to senior level scientists or managers. Obtained and recorded test data in a manner consistent with cGMPs. Wrote Operation and Maintenance SOPs. Performed calibration, check program and preventative maintenance and trouble shoot and repair as needed. Wrote SOPs for optimal use in QC. Followed cGMP regulations and ICH guidelines.

Aug 2002Sep 2003

Microbiology Technician

Office of Regulatory Affairs (FDA)

Preparation of media and other analytical processes in compliance with national food safety regulations. Writing SOP's; Following GLP and GDP guidelines; laboratory budget analysis; Inventory; Ordering for the lab ; Quality Assurance and Control Procedures; Evaluation of current lab practices and independent initialization of start up procedures for new lab practices and lab organization for ISO accreditation. Sample analysis training. Monitoring and calibration of lab equipment (autoclaves, pH meters, water baths, refrigerators) in order to keep within regulatory compliance. Creation of new worksheets and spreadsheets for data recording. Completion of ORAU training modules for analyst - which includes knowledge of the FD&C Act (and additions made to the act) and investigative practices and laws within the FDA. Knowledge of regulatory actions in sample handling and processing (including relevant paperwork and documentation).

Jan 2000Aug 2002

Quality Control Chemistry Analyst

Baxter BioScience

Perform quantitative and qualitative analyses on a variety of plasma-based samples and raw materials. Performed routine gas chromatography assay using methods in SOPs following cGMPs. Performed investigations after Out-of-Spec. results by communicating with plant and lab personnel. Was responsible for sample testing from inception of sample into the quality laboratory to the release of the sample lot. Was responsible for modifying SOPs to meet specific testing methods as needed. Performed a monthly review of assigned SOPs to determine if proper procedures were being followed. Extensive use of MSDS, USP specifications, and FDA regulations, laboratory maintenance, equipment trouble-shooting, ordering supplies, methods validation projects, design of experiment protocols, and Gas Chromatography.

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Education

Nov 2012Present

Certification

Villanova University
Sep 1994May 1999

Bach of Science

Louisiana Tech University