QC Chemist

Job Title:

QC Chemist

Job Description

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.

Essential Skills

+ 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, protocols, reports, and material specifications.

+ Capacity to perform routine maintenance and basic troubleshooting on QC instrumentation.

+ Ability to assess whether materials meet specifications for release based on analytical results.

+ Physical ability to lift up to 25 pounds as part of laboratory duties.

Additional

Skills & Qualifications

+

Experience with data management systems such as Chemstation or Chromeleon.

+ Familiarity with NMR and broader…