Quality Control Analyst

This role focuses on performing routine and project-based qPCR testing to support in-process and finished product quality control in a GMP pharmaceutical environment. The Quality Control Analyst conducts time-sensitive qPCR assays, handles raw material and finished product samples, supports method validation and development, and contributes to environmental and contaminant monitoring in a brand-new laboratory operating around the clock.

Responsibilities

• Perform routine qPCR testing on samples with a 7-hour turnaround time, working in parallel with another analyst to ensure timely completion.
• Conduct in-process testing on raw materials, primarily pig-origin tissue slurries, including extraction of RNA from tissue samples.
• Perform finished product testing on final drug product and select specialty products, including some testing for additional sites.
• Run speciation assays to identify and quantify different species within a sample.
• Carry out contaminant monitoring and positive control environmental monitoring while samples are running.
• Perform calibration and routine maintenance of laboratory instruments, including centrifuges, spectrophotometers, and liquid handler robots.
• Prepare reagents, manage inventory, and ensure that all necessary materials are available and properly documented.
• Support validation activities, including validating basic centrifuges, spectrophotometers, liquid handler robots, laboratory software, and lab spaces.
• Assist with software programming related to qPCR and laboratory instruments as part of validation and method support.
• Draft and support laboratory methods, including method development and documentation in accordance with GMP and FDA expectations.

Requirements

• Associates or Bachelor’s degree in Microbiology or a related discipline preferred for all levels.
• High School Diploma or G.E.D. required for all levels.
• Minimum of 1 year of working in a regulated laboratory environment.
• Experience with pipettes required.
• PCR experience from school or industry is preferred but not required.
• Open to different experience levels: Associate, Analyst, and Senior.

Schedule

Third shift, Monday through Thursday, working 10-hour days starting at 9:00 p.m.

Pay

The pay range for this position is $45,760.00 - $75,000.00 per year.

Benefits

• Medical, Dental, and Vision coverage starting on Day 1.
• Life and AD&D Insurance.
• Short and Long-term Disability.
• Health and Flexible Saving Account options.
• Employee Assistance Program.
• Generous vacation and paid holidays.
• 401k retirement plan.

Work Environment

This is a fully onsite position in Madison, WI.