Quality Control Raw Materials

David Beres

(David is local to Lincoln University, PA, and is available for an interview with 24–48 hours of prior notice.)

Email : *************@*****.*** Phone : 717-***-****

Summary:

Detail-oriented and motivated Chemist/Lab Analyst with a Bachelor's degree in Chemistry.

Extensive experience in performing quality control tests on raw materials, intermediates, and finished products.

Proficient in operating HPLC/UPLC systems using Empower software.

Skilled in applying Good Laboratory Practices (GLP) and working in a Good Manufacturing Practice (GMP) environment.

Demonstrated expertise in raw material analysis following USP, EP, BP, and JP pharmacopeial methods.

Strong background in using High-Performance Liquid Chromatography (HPLC) techniques to ensure analytical accuracy and product quality.

Skills:

High-Performance Liquid Chromatography (HPLC)

Ultra-Performance Liquid Chromatography (UPLC)

Gas Chromatography (GC)

IR Spectroscopy

Osmometer

Wet Chemistry

Chromatography

Laboratory Equipment

Raw Materials Testing

Data Analysis

Analytical Skills

Quality Control

Validation

USP/EP/JP Compliance

LIMS

Good Manufacturing Practice (GMP)

Current Good Manufacturing Practice (cGMP) Practices

Good Laboratory Practice (GLP)

Investigation

Testing

Laboratory Skills

Problem-Solving

Education & Certifications:

Bachelor of Arts - BA, Chemistry, Millersville University of Pennsylvania

Teaching Certification

Professional Experience:

Pfizer, McPherson, KS Mar 2023 – Jan 2024

Chemist

Monitored and maintained the DI water system.

Performed method validations and method transfer.

Operated HPLC/UPLC systems using Empower software.

Executed validation processes for raw materials and finished product data, maintaining high accuracy and reliability.

Performed method validations and assisted in process validation, ensuring compliance with regulatory standards.

Entered data into MS Excel spreadsheets and prepared reports of findings using MS Word.

Operated and calibrated laboratory instruments, including IR and HPLC, for precise sample analysis.

GSK, Carlisle, PA Mar 2016 – Nov 2021

Chemist

Performed IR identification on finished goods.

Conducted OOS investigations on out-of-specification results and abnormal observations.

Performed testing and sample preparation according to compendia and SOPs.

Conducted rigorous quality testing on finished products, in-process and validation samples, adhering to SOPs and maintaining high standards of sample handling and data integrity.

Coordinated with various departments to facilitate sample processing and analysis within established timelines.

Additional Projects:

Chemist, Lancaster Labs, Lancaster, PA (Oct 1997 – Mar 1999)

Maintained chemical inventory and ordered supplies as required.

Performed raw material analysis using USP/EP/BP/JP methods.

Conducted USP analysis on final products, including raw materials.

Implemented good laboratory practices (GLP) in a GMP environment to maintain high-quality results.

Lab Analyst, J&J Merck, Lancaster, PA (Oct 1993 – Mar 1995)

Performed HPLC analysis of in-process, finished goods and stability samples.

Trained lab personnel on HPLC.

Adhered to laboratory policies to maintain safety and compliance standards.

Analyzed raw materials and finished products for internal and external quality assurance.

Lab Analyst, Warner Lambert, Lititz, PA (Jan 1989 – May 1991)

Performed GC analysis of finished goods.

Used UV/Vis, Colorimeter, Viscometer, and pH meter.

Prepared and standardized sample solutions, reagents, and controls to ensure accurate testing outcomes.

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