Associate QC Chemist

5w1 month ago

Unither Pharmaceuticals

Rochester, US · Full-time · $44,000 – $50,000

About this role

This Associate QC Chemist role reports to the QC Supervisor - Finished Products and performs analyses of materials, drug substances, and drug products following cGMPs. The position supports method development activities and performs method validations under supervision.

Daily responsibilities include executing analytical lab tests, maintaining instruments and equipment, and performing routine calibrations. The chemist proactively identifies issues, communicates solutions, and participates in laboratory troubleshooting and investigations.

The role works within a quality-focused lab environment that emphasizes compliance with SOPs, cGMPs, and regulatory requirements including FDA, DEA, USP, EP, and OSHA. Team members also implement training to ensure GMP and customer requirements are met.

This position supports method development and validation, offering opportunities to deepen expertise in analytical techniques such as HPLC, dissolution, and spectroscopy. The chemist also contributes to improvements in lab quality systems and training effectiveness.

Requirements

Associate's degree with 5+ years or Bachelor's degree with 2+ years of experience in chemistry or related science discipline.
Experience with laboratory analytical techniques.
Ability to operate and maintain HPLC systems, dissolution equipment, and spectroscopic instrumentation (UV/Vis, FTIR).
Experience with HPLC method development and validation in a pharmaceutical environment (desirable).
Experience in written notebook documentation practices.
Basic Outlook skills and intermediate Microsoft Word skills.

Responsibilities

Performs, interprets, evaluates, and records routine and non-routine analytical lab tests of materials, drug substances, and drug products following cGMPs.
Maintains instruments and equipment, sets up instruments, conducts sample tests, and performs routine calibrations.
Supports method development, validation, and method transfer activities.
Proactively identifies issues, communicates and proposes solutions, and performs laboratory troubleshooting.
Supports investigations and writes basic investigation reports under supervision.
Implements training to ensure GMP, regulatory, and customer requirements are met, and monitors training effectiveness.
Maintains laboratory compliance with SOPs, cGMPs, HS&E requirements, and FDA, DEA, USP, EP, and OSHA regulations.