Product Development Quality Control
Resume:
Tyler Pentek
Education
Pharmaceutical/Chemical Product Development Master’s of Science Degree &
Masters of Business Administration Certificate
Concordia University Wisconsin [08/2014-05/2016]
Developed a Resveratrol-Dendrimer topical cream formulation from bench top to commercial scale (University Owned-Patent Filed).
Cosmetic formulation supplied to a NY based cosmetic company for human volunteer testing.
Developed in-depth knowledge of 21CFR, 35 USC and multiple regulatory agencies including: PTO, SEC, IRS, DEA, OSHA, EPA, FTC and CMS.
Proficiency in HPLC and UV-Spectroscopy analysis along with the analytical method development skill.
Proficiency in GC, Karl Fischer, FTIR, Raman, and Mass Spectroscopy analysis.
Established proficient instrument troubleshooting and repair skills.
Well versed with various formulation and scale-up steps.
Experience in creating business plans and intellectual property documents.
Bachelor’s Degree of Letters and Science – Biology
Bachelor’s Degree of Letters and Science - Environmental Studies
University of Wisconsin-Madison [08/2011-05/2014]
Researched in-depth on Melanoma Cancer and the study of how the cancer forms and grows along with current available treatments.
Gained knowledge of biological concepts & environmental concepts.
Understanding of in-depth theories and practices in the functional areas of biology.
Professional Experience
Quality Engineer
AMMO Incorporated [03/2022-Present]
Develop and maintain quality systems and procedures along with creating/modifying/analyzing inspection plans, quality performance trends, statistical plans, cost estimates and technical quality plans for proposals
Ensure all documentation and processes/procedures are compliant with requirements and/or contracts
Generate reports by analyzing data and proposing changes in methods/materials.
Write/generate training material(s) and conduct training sessions for quality control activities
Conduct root cause analysis and implement corrective actions (8D, 5Why’s, etc.)
Lead and motivate employees and team members
Develop and implement methods/procedures for inspecting, testing and evaluating the precision, reliability, and accuracy of products, processes and production equipment
Manage and issue return authorizations when customers have issues with product(s)
Provide guidance and troubleshooting help to all production employees.
Update and make adjustments to all specifications for all products
Manage the calibration of all gages and repair all gages used within the facility
Disposition non-conforming items to ensure all products remain safe for customer use
Lean Six Sigma Green Belt
Lean Six Sigma Yellow Belt
ISO 9001 Certified Auditor
Quality/Sanitation Supervisor
Masters Gallery Foods Inc. [01/2021-03/2022]
Provide guidance and supervision to direct report employees.
Inspect cheese, ingredients, raw materials and finished goods to ensure quality standards are met.
Inspect finished goods for impurities/foreign materials.
Ensure all sanitation practices are followed by employees and equipment is clean prior to use.
Ensure GMP’s are followed by all employees in the facility.
Knowledge and use of ERP/Atrium software programs.
Complex problem solving
Knowledge of several regulatory agency’s standards/guidelines (FDA, EPA, ISO, BRC, OSHA, and others)
Lean Six Sigma Yellow Belt
PCQI Certified
Operational Quality/Quality Assurance Supervisor
Sargento Foods Inc. [07/2018-01/2021]
Provide guidance and supervision to direct report employees.
Inspect cheese, ingredients, raw materials and finished goods to ensure quality standards are met.
Inspect finished goods for impurities/foreign materials.
Ensure GMP’s are followed by all employees in the facility.
Knowledge and use of SAP and Savanah software programs.
Complex problem solving
Knowledge of several regulatory agency’s standards/guidelines (FDA, EPA, ISO, BRC, OSHA, and others)
Lean Six Sigma Yellow Belt
Analytical Chemist
Kleen Test Products Corporation [11/2016-06/2018]
Developed proficient skills in quality control and analytical techniques.
Strong attention to key details within batch records, methods, analytical analysis, errors, etc.
Advancement of excellent problem-solving skills.
Strong mathematical skills including fractions, percentages, ratios, etc.
Proficiency in writing/editing new raw material specifications and test methods
Gained experience at Karl-Fischer Titrations, IR-Spectroscopy, Appearance, Odor, Manual Titrations, Auto Titrations, HPLC, and GC testing.
Familiarity of GMP & GLP practices.
Proficiency with Microsoft office (Excel, Word, PowerPoint, etc.)
Update current raw material specifications.
Analytical/Chemistry Intern
Kleen Test Products Corporation [11/2015-11/2016]
Proficiency in writing/editing new raw material specifications and test methods
Gained experience at Karl-Fischer Titrations, IR-Spectroscopy, Appearance, Odor, Manual Titrations, Auto Titrations, HPLC, and GC testing.
Developed proficient skills in quality control and analytical techniques.
Advancement of excellent problem-solving skills.
Familiarity of GMP & GLP practices.
Update current raw material specifications.
Quality Control Intern
Cambridge Major Laboratories Inc. [09/2014-04/2015]
Gained experience in HPLC, GC, IR, UV-Vis Spectroscopy Analysis, KF titrations and appearance testing for API’s
Advancement of skills in analytical method development.
Familiarity of GMP & GLP practices.
Attention to key details within analytical testing, errors, etc.
Publications
Pentek, T., Newenhouse, E., O’Brien, B., & Chauhan, A. (2017). Development of a Topical Resveratrol Formulation for Commercial Applications Using Dendrimer Nanotechnology. Molecules,22(1), 137. doi:10.3390/molecules22010137
Volunteer Activities
Waterfowl Banding with the Wisconsin Department of Natural Resources
Sheboygan County Greenwing Day Volunteer Instructor sponsored by Ducks Unlimited
References: Available upon request
2711 South 19th Street 920-***-****
Sheboygan, WI 53081 ********@*****.***
Contact this candidate