Quality Control HPLC

Job Description

Quality Control is responsible for performing analytical testing and sampling to support manufacturing, validation, process development, and stability studies in a GMP-regulated environment. This role requires strong expertise in HPLC and may support or lead continuous improvement, validation, and method development initiatives.

Key Responsibilities

Perform and review routine analytical assays using HPLC in strict accordance with approved test methods and SOPs.

Conduct aseptic sampling, visual inspections, gowning, and work in cleanroom environments

Review, revise, and author analytical test methods, standard operating procedures, and perform trending analyses.

Serve as study lead for validation projects, investigations, and method development activities, as assigned.

Prepare study protocols, reports, and documentation; train and mentor other analysts.

Collaborate cross-functionally to develop, revise, and implement QC procedures and policies.

Participate in regulatory inspections and demonstrate laboratory compliance with FDA and CFR requirements.

Utilize analytical instrument software to perform calculations, reducing manual errors and improving efficiency.

Perform other duties as assigned.

Minimum Qualifications

Bachelor’s degree in Chemistry, Biology, or a related scientific field, plus 2–4 years of industry experience in a QC or analytical laboratory, or an equivalent combination of education and experience.

Hands-on experience with analytical testing, laboratory instrumentation, report writing, SOPs, GMP compliance, and regulatory audits.

Strong background in HPLC, analytical biochemistry, and chemistry.

Experience with most or all of the following:

Protein characterization

Electrophoresis

Chromatography techniques (normal phase, reverse phase, size exclusion, ion exchange, etc.)

Aseptic techniques

Assay development and validation/qualification

Full-time