Quality Control Chemist

SUMMARY

We are seeking an experienced Quality Control Chemist to support laboratory operations within a regulated pharmaceutical manufacturing environment. This position focuses on analytical testing, batch release activities, stability programs, and collaboration with production and quality teams to help maintain product quality and manufacturing timelines. The ideal candidate will bring strong hands-on experience working with solid oral dosage products and modern analytical instrumentation in a fast-paced cGMP setting.

RESPONSIBILITIES

• Perform routine analytical testing for raw materials, in-process samples, and finished products using established laboratory methods.
• Support batch release and stability testing activities for tablet and capsule manufacturing operations.
• Operate and troubleshoot laboratory instrumentation including HPLC, UPLC, GC, UV, FTIR, dissolution systems, and Karl Fischer equipment.
• Complete laboratory documentation in compliance with cGMP, FDA, and ALCOA data integrity standards.
• Assist with investigations involving deviations, OOS/OOT results, and corrective action activities.
• Coordinate stability sample handling, storage, tracking, and trending activities.
• Conduct routine calibration, maintenance, and performance checks on laboratory equipment.
• Work closely with Quality Assurance and Manufacturing teams to support production schedules and quality objectives.
• Maintain organized, audit-ready records and contribute to continuous improvement initiatives within the laboratory.

QUALIFICATIONS

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline preferred.
• Minimum of 6 years of recent pharmaceutical Quality Control laboratory experience in a cGMP-regulated environment.
• Hands-on experience supporting solid oral dosage manufacturing processes such as tablets and capsules.
• Strong working knowledge of analytical testing including assay, dissolution, impurity, and related substances analysis.
• Recent experience operating HPLC and UPLC systems is required.
• Familiarity with Empower, LIMS, FDA, ICH, and cGMP requirements.
• Experience supporting stability programs, finished product release, and laboratory investigations.
• Strong attention to detail, documentation practices, and organizational skills.
• Ability to work effectively in a fast-paced manufacturing support environment.

BENEFITS

• Opportunity to work in a highly regulated pharmaceutical manufacturing environment with advanced laboratory technology.
• Exposure to cross-functional collaboration with Quality, Manufacturing, and Regulatory teams.
• Stable, hands-on laboratory role supporting meaningful production and quality initiatives.
• Professional growth opportunities within quality operations and pharmaceutical manufacturing.
• Competitive compensation and comprehensive benefits package.