QC Chemist
Listed on 2026-08-11
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
The QC Chemist works in a quality control laboratory within a pharmaceutical and specialty chemical manufacturing environment in the Milwaukee area. This role focuses on release and in-process testing of raw materials, intermediates, and finished API products using a wide range of analytical instrumentation. The QC Chemist interprets chromatography data, manages analytical documentation in compliance with GMP requirements, and contributes to method and analytical development in a growing, expansion-focused organization.
Job Title:QC Chemist
The QC Chemist works in a quality control laboratory within a pharmaceutical and specialty chemical manufacturing environment in the Milwaukee area. This role focuses on release and in-process testing of raw materials, intermediates, and finished API products using a wide range of analytical instrumentation. The QC Chemist interprets chromatography data, manages analytical documentation in compliance with GMP requirements, and contributes to method and analytical development in a growing, expansion-focused organization.
Responsibilities- Perform release and in-process testing of raw materials, intermediates, test materials, and finished API products in accordance with written methods and procedures.
- Follow all applicable procedures, specifications, and test methods, ensuring full compliance with internal and regulatory requirements.
- Execute wet chemistry and analytical chemistry techniques to support quality control activities.
- Operate and utilize laboratory instrumentation, including HPLC, GC, FTIR, UV-Vis, Karl Fischer (KF), IC, and a soon-to-be-installed ICP-MS, to perform routine and specialized analyses.
- Interpret chromatography data and other analytical results, using data management systems such as Chemstation or Chromeleon where applicable.
- Assess whether materials meet specifications for release and document decisions clearly and accurately.
- Perform and review critical and complex calculations to support analytical testing and data evaluation.
- Prepare and standardize volumetric solutions to support routine and non-routine testing.
- Clearly document all GMP activities accurately and legibly, maintaining complete and compliant laboratory records.
- Perform routine maintenance and basic troubleshooting on QC instrumentation to ensure reliable operation.
- Review data calculations for validation activities and ensure accuracy of analytical results.
- Provide information and documentation responses in cases of customer complaints or returns, supporting investigations and resolutions.
- Write procedures, test methods, protocols, reports, and material specifications to support laboratory operations and continuous improvement.
- Support a culture of consistent compliance by participating in training, providing guidance, and reviewing procedures as needed.
- Meet deadlines and testing schedules established by quality control leadership.
- Participate in a structured training process, progressing from observing tests, to performing tests under supervision, to independently executing tests.
- Handle laboratory supplies such as columns, liners, and septa, and ensure proper setup and use of analytical equipment.
- Lift up to 25 pounds as needed to handle materials, reagents, and equipment in the laboratory.
- Bachelor’s degree in a science discipline such as Chemistry, Biochemistry, or Biology.
- 2–3 years of experience as a chemist in an industrial setting.
- Hands‑on experience with HPLC and GC in a quality control or analytical laboratory environment.
- Proficiency with laboratory instrumentation, including HPLC, GC, FTIR, UV-Vis, Karl Fischer (KF), and IC.
- Ability to interpret and review analytical and chromatographic data accurately.
- Strong competency in performing and verifying critical and complex calculations.
- Experience working under GMP or similar regulated quality systems, with the ability to document activities clearly and legibly.
- At least 2 years of experience using Excel for data analysis, reporting, and documentation.
- Capability to prepare and standardize volumetric solutions and perform wet chemistry techniques.
- Ability to write clear and concise procedures, test methods,…
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