QC Scientist - HPLC

Job Title:

QC Scientist IJob Description

• Perform HPLC and UPLC testing for in-process drug substance release, drug product release, drug substance stability, drug product stability, process validation, analytical method validation and transfer, method establishment and qualification, and various non-routine samples.

• Conduct GMP-compliant testing in an analytical laboratory environment using HPLC and UPLC test methods, including Reverse Phase, SEC, titer/concentration, and CEX assays.

• Accurately record, analyze, and report test results in accordance with established laboratory procedures and quality systems.

• Recognize out-of-specification and out-of-trend results, promptly report them to laboratory management, and recommend appropriate solutions or follow-up actions.

• Maintain, operate, and troubleshoot analytical instruments and associated laboratory equipment to ensure reliable performance and minimal downtime.

• Perform method validation and qualification testing as required to support new or existing analytical methods.

• Author and review standard operating procedures, test methods, forms, and related documentation within the electronic document management system (eDMS).

• Demonstrate proper laboratory safety and housekeeping practices, including participation in weekly 5S laboratory audits and monthly laboratory inspections, ensuring all activities meet EHS requirements.

• Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable safety guidelines.

• Work collaboratively with internal and external customers to maintain clear and open communication when raising, resolving, and following up on issues.

• Partner with QC leads, project managers, and clients to support the overall health and success of client programs.

• Contribute to a culture of continuous improvement in laboratory practices, documentation quality, and analytical workflows.

• 0–2 years of hands-on HPLC and UPLC experience in a quality, analytical, pharmaceutical, or closely related industry environment.

• Experience performing HPLC/UPLC assays, with familiarity in methods such as SEC, CEX, glycans, and peptide mapping considered a strong advantage.

• Working knowledge of GMP regulations and experience operating within a cGMP manufacturing or quality control environment.

• Foundational understanding of scientific principles underlying a wide range of analytical techniques in analytical chemistry and wet chemistry.

• Ability to follow and apply Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Standard Operating Procedures (SOPs), and safety guidelines in daily work.

• Strong attention to detail and accuracy in documenting, analyzing, and reporting laboratory data.

• Ability to identify out-of-specification and out-of-trend results and communicate findings clearly to laboratory management.

• Basic troubleshooting skills for analytical instruments and laboratory equipment.

• Effective communication skills for collaborating with QC leads, project managers, and external partners.

• Ability to work independently at the bench while adhering to established quality and safety standards.

• Prior experience with EMPOWER chromatography data software is preferred but not required.

• Experience with a variety of HPLC/UPLC assays, including SEC, CEX, glycans, and peptide mapping, is considered a plus.

• Background in quality control, analytical chemistry, and wet chemistry in a regulated environment.

• Strong working knowledge of scientific principles for a broad range of analytical techniques is strongly preferred.

• Interest in professional development and continuous learning within a high-performing scientific organization.

• Ability to contribute to and thrive in a culture that values innovation, R&D investment, and meaningful impact on global health.

This is a bench-focused laboratory role in an analytical QC environment, working Monday through Friday from 8:00 a.m. to 4:30 p.m. The position involves routine and non-routine testing using HPLC and UPLC systems and related analytical equipment, with a strong emphasis on GMP, GLP, and safety compliance. The laboratory operates under structured procedures and quality systems, including use of an electronic document management system for SOPs and test methods.

The culture emphasizes continuous growth, learning, and empowerment, providing resources and opportunities for professional development while contributing to impactful work in the life sciences sector. Appropriate laboratory attire and adherence to safety and housekeeping standards are expected at all times.

This is a Contract to Hire position based out of Berkeley, MO.

The pay range for this position is $28.00 - $31.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge,…