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Product Development Quality Control

Location:
Sheboygan, WI
Posted:
February 07, 2024

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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 ad3goq@r.postjobfree.com



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