Analytical Chemist

TekWissen•High Point, NC

9h•Onsite

About The Position

The Analytical Chemist performs chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples in a GMP-regulated laboratory. The work includes routine and non-routine testing using validated, internally developed, and compendial methods to assess product strength, impurities, identity, and other quality attributes. The role operates analytical instruments such as HPLC, GC, spectroscopy equipment, and traditional wet chemistry instruments; investigates out-of-specification results and unexpected findings; troubleshoots methods and equipment; and documents and communicates results accurately. The position supports laboratory operations and quality improvement while maintaining compliance with FDA regulations, GMP, GLP, SOPs, data-integrity requirements, and laboratory safety guidelines.

Requirements

Bachelor's degree in Chemistry.
At least 3 years of hands-on chromatography experience using HPLC and GC.
Experience working in a GMP- and FDA-regulated pharmaceutical laboratory.
Strong knowledge of analytical chemistry, pharmaceutical quality control testing, and validated analytical methods.
Hands-on experience operating and troubleshooting HPLC and GC instrumentation and interpreting analytical data.
Knowledge of spectroscopy, quantitative and qualitative analysis, and traditional wet chemistry techniques.
Familiarity with pharmaceutical raw material, finished product, and stability testing, and analytical method execution.
Understanding of OOS results, analytical investigations, and laboratory troubleshooting procedures.
Working knowledge of GMP, GLP, SOPs, and FDA regulatory requirements.
Experience with chromatographic data acquisition systems and common office software applications.
Strong analytical thinking, independent problem-solving, and troubleshooting abilities.
Excellent attention to detail and ability to maintain accurate laboratory documentation and testing records.
Strong written and verbal communication skills.
Ability to work independently, manage laboratory priorities, and collaborate effectively with cross-functional teams.
Strong organizational skills and commitment to laboratory safety, data integrity, and regulatory compliance.

Nice To Haves

Experience with Empower 3 chromatography data acquisition software.

Responsibilities

Perform chemical and physical testing of pharmaceutical raw materials, finished products, and stability samples using internally developed and compendial test methods.
Conduct analytical testing for product strength, impurities, identity, and other quality attributes using validated analytical methods.
Operate HPLC, GC, spectroscopy equipment, and traditional wet chemistry instruments.
Perform qualitative and quantitative chemical analysis using chromatography, spectroscopy, and conventional laboratory techniques.
Identify, investigate, and report out-of-specification results, unexpected analytical findings, and non-routine product issues.
Troubleshoot analytical methods and laboratory instrumentation, and recommend appropriate corrective actions.
Perform routine maintenance and troubleshooting of analytical equipment to ensure accurate and reliable testing.
Document testing procedures, observations, calculations, and results in accordance with laboratory procedures.
Review, interpret, and communicate analytical data and test results clearly and accurately.
Maintain laboratory records and report analytical results using approved documentation systems and chromatographic data acquisition software.
Collaborate with cross-functional departments to communicate testing results, resolve analytical issues, and support laboratory operations.
Maintain clean, organized, and safe laboratory workspaces, instruments, and testing materials.
Ensure compliance with SOPs, GMP, GLP, FDA regulations, and laboratory safety guidelines.
Maintain laboratory compliance standards and participate in continuous quality improvement activities.