Paul Karl
Waynesboro,PA
Summary
Senior Quality Control Analyst with 20 years of quality assurance and laboratory expertise. In-depth experience in a wide variety of analytical techniques, methods, and instrumentation. Proficient in collaborating with multidisciplinary teams and exhibiting leadership while working with government agencies. A valuable team member with a proven ability to develop process and product improvements that strategically align to help increase overall effectiveness and efficiencies in quality systems.
Overview
25
25
years of professional experience
Work History
Quality Control Laboratory Technician
Procter and Gamble
Inwood, WV
05.2018 - Current
- QC Analyst responsible for analysis, release, review of raw material, in-process, and finished product analytical test criteria.
- Prioritizing test scheduling, maintain data integrity/ data review, ALCOA+, and SAP data entry
- Establishing day to day efficiency of the QC laboratory as production scale up, new production lines added, and additional test methods/ instrumentation are needed.
- Receipt of production samples, in-process and raw material samples, checking that all pertinent information is received correctly
- Instrument, computer system validation, analytical method transfer
- Root cause analysis, quality failure investigations and reporting, data integrity review
- GMP Audit Readiness, review of laboratory reporting systems and notebooks
- Continuous improvement, Automated Maintenance Program (AM) participation, 5S ownership and Audit responsibilities
- Conduct Weekly Health and Safety Audits
- Training of fellow employees on qualified test methods
- Site Di-Water collection using aseptic technique.
- Site ownership of the laboratories Agilent 8453, Cary 60 UV-Vis
- Author and maintain SOPs and Job-aids for the UV-Vis instrumentation and methods maintained in Veeva document control system
- Act as interim/ Back-up Laboratory Shift Lead
- Conduct beginning of shift directional meetings with the QC laboratory team and attend QA/QC leadership morning briefings.
- Analytical testing include 1,4-Dioxane, unreacted fatty alcohol, anionic titrations, alkalinity, particle size characterization, sensory characterization, raw material identification (FTIR), Karl Fisher, viscosity, rheology, pH, density, specific gravity.
- Instrumentation and Operating Systems
- SAP and Proficy data management systems , Agilent 8860 GC and Agilent 1260 HPLC using Chromeleon CDS, Metrohm Tiamo Titrando Titration system, Perkin Elmer FTIR, Agilent UV-Vis with Chemstation OS, Horiba Partica LA-960, TA Rheometer with Trios OS, Brookfield LV,RV and RST viscometers, Nexus LIMS, Veeva Vault, Enova document control systems.
QA Supervisor
HADLEY FARMS INC.
Smithsburg, MD
09.2015 - 04.2018
- Oversaw the continuous progress of daily production to ensure the achievement of product quality specifications, taking necessary corrective actions and promptly addressing inconsistencies when appropriate. Routinely monitoring of site HACCP program. Guide production in the collection and inference of various quality data. Assist in training and development of new and current employees.
- Maintain records of critical control points addressing food safety issues and regulatory compliance HACCP
- Confirm all product is baked, labeled, packed, and ready for distribution for Hadley Farms Inc. in a safe and wholesome manner, meeting customer standards for food safety and quality
- Pulled daily product samples and tested per QA standards
- Key Accomplishments
- Assisted with the implementation of new Federal protocols that establish compliance with the Food Safety Modernization Act (FSMA)
- Support the implementation of new training protocols and regulatory standards, ensuring the quality of the finished products
- Proactively solve problems regarding work demands, team issues, and efficiency by collaborating with management team
- Effectively evaluate all site-wide processes and certify the proper specifications, standard procedures and training associated to the QA department are being met and followed
Environmental Chemistry /Analyst
Lockheed Martin
Hanover, MD
09.2005 - 09.2013
- Working as a member of the Environmental Sciences Assistance Team (ESAT), key analyst responsible for EPA Region III laboratory Client Service (ESAT) at the Environmental Science Center (ESC), Fort Meade, MD.
- Analytical analysis and instrument maintenance for Lead (Pb), Iron (Fe) Mercury (Hg) Cation in Waste water: wet chemistry, toxic metals, instrument proficiency testing., Using EPA Methods 300.0, 200.7, 200.8, 218.6, SW846, 405.1, and 310.2 under the Superfund, Clean Water Act (CWA), Resource Conservation and Recovery Act (RCRA), Safe Drinking Water Act (SDWA)
- Qualified as PM 2.5 and Through-The-Probe auditor under the Clean Air Act (CAA).
- CGMP compliance and laboratory audits, data validation of quality reports to support accreditation and ISO 9001 compliance readiness
- Closely involved with cross-organizational implementation of method development with laboratory instrumentation, analytical procedures, and Quality Control programs, and NELAP ISO 9001 accreditation audit readiness
- Coordinated project plans between EPA staff, team staff, and third party contractors to establish consensus concerning time sensitive projects.
- Assisted EPA and Lockheed Martin management in the procurement of instrumentation and largescale laboratory devices for the establishment of new agency programs.
- Preparation and Review of analytical reports and documentation control.
- Other duties include- Served as the Lockheed Martin Health Safety and Waste Committee representative for facility ISO 9001 issues, review and revisions of laboratory waste flow charts, laboratory walk throughs to maintain compliance with ESC Safety Health and Environmental Management (SHEM) and ISO 9001 requirements and audits. Participate in the implementation of the facility wide Environmental Management System (EMS). Monitor the flow of chemical waste throughout responsible laboratories. Maintain MSDS records for chemicals stored in responsible laboratories.
- Analytical instrumentation experience includes: DIONEX-600 IC, DIONEX 5000 Liquid Chromatography, Perkin Elmer Optima 4300 DV ICP, Leeman 200PSII Mercury Analyzer, BGI air particulate sampler, Tisch High volume air sampler, Thermo Fisher AGGPS Ozone monitor, Thermo Fisher 48C CO monitor.
- Software experience includes: Promullem Element LIM system, Chromeleon Chromatography Management System, Perkin Elmer WinLab32.
- Key Accomplishments:
- Key analyst in charge of EPA Region III laboratory Client Service (ESAT) at the Environmental Science Center (ESC)
- Served as the Lockheed Martin Health Safety and Waste Committee representative for facility ISO 9001 issues
- Facilitated procurement of instrumentation and largescale laboratory devices for the establishment of new agency programs on behalf of the EPA and Lockheed Martin
Analytical Analyst
Microbac Laboratories
Baltimore, MD
07.2001 - 09.2005
- Conducted analytical testing to support the development and validation of analytical methods inorganic metal and mineral analysis under the scope of EPA Safe Drinking Water Act, 40 CFR and NELAC Accredited, Using EPA methods 200.7, 200.8, 245.1, SW846. Metals/ mineral reporting included Lead (Pb), Iron (Fe) Magnesium (Mg), Manganese (Mn), Nickel (Ni) Aluminum (Al), Sodium (Na), Potassium (K), Silicon (Si) , Lithium (Li) Mercury (Hg) among others. Assured product quality and proper inventory utilization by assigning appropriate personnel to confirm the consistent achievement of product specifications. Developed and validated analytical methods under cGMP compliance in support of pharmaceutical and biological product development to maintain AZLA, NELAC accreditation, product development, failure analysis and product problem solving.
- Maintained laboratory supply inventories and updated standard operating procedures
- Assisted laboratory personnel with instrument maintenance and repairs to ensure the analytical laboratory maintained proper working order
- Assisted laboratory personnel with instrument maintenance and repairs to ensure the analytical laboratory maintained proper working order
- Key Accomplishments:
- Trained laboratory personnel and championed optimal efficiency during the entire laboratory process
- Effectively communicated with multiple departments and personnel to create synergies and assure compliance with all company standards, policies and regulatory agencies
Education
Bachelor of Science - Physical Science
Auburn University at Montgomery
Montgomery, AlabamaSkills
- Standard operating procedures
- Quality Systems
- Laboratory Audits
- Good manufacturing practices
- Customer focus
Timeline
Quality Control Laboratory Technician
Procter and Gamble
05.2018 - Current
QA Supervisor
HADLEY FARMS INC.
09.2015 - 04.2018
Environmental Chemistry /Analyst
Lockheed Martin
09.2005 - 09.2013
Analytical Analyst
Microbac Laboratories
07.2001 - 09.2005
Bachelor of Science - Physical Science
Auburn University at Montgomery