Quality Control Analyst (2nd shift)

Help ensure the quality and reliability of medicines that make a meaningful difference for patients. As a Quality Control Analyst, you will perform chemical and microbiological testing of products, raw materials, and packaging components while supporting the readiness and day-to-day execution of Quality Control operations. You will work with analytical instrumentation, environmental monitoring, sterility testing, investigations, and documentation while maintaining high standards for quality, safety, and regulatory compliance.

Please note: This 2nd shift role will work a 4x10 schedule. Shift hours are expected to be 3:00 pm-1:30 am either Sun – Wed or Wed – Sun. Please indicate your preference when you apply. Adjustments to the schedule may be necessary based on business need.

Key Responsibilities

• Perform chemical and microbiological testing of raw materials, finished products, and packaging components.
• Execute environmental monitoring and sterility testing while maintaining compliance with GMP requirements.
• Prepare, operate, clean, and maintain Quality Control equipment, reagents, materials, and testing areas.
• Manage samples, document testing activities, report results, and escalate deviations or nonconformances.
• Support investigations, corrective and preventive actions, change controls, and associated procedure and form revisions.
• Participate in equipment, method, and process qualification and validation activities as assigned.
• Prepare accurate analytical records and support internal and external audits and regulatory inspections.

Essential Requirements

• Bachelor's degree in Chemistry, Microbiology, or another relevant scientific discipline.
• Minimum two years of experience working in a GMP or aseptic environment.
• Hands-on experience with physicochemical techniques and analytical instrumentation, including HPLC, GC, and iTLC.
• Knowledge of GMP regulations and FDA guidance applicable to Quality Control testing.
• Understanding of aseptic principles and techniques, including environmental monitoring and sterility testing.
• Ability to interpret analytical data and translate results into clear, accurate technical documentation.

Desirable Requirements

• Experience supporting deviation investigations, corrective and preventive actions, change controls, or qualification and validation activities.
• Experience working with Quality Control testing and documentation in an RLT or radio pharmaceutical environment.