Quality Control Analyst

Quality Control Analyst (PCR) - 3rd Shift

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.

• 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.
• Operate laboratory equipment such as microbalances, fume hoods, biosafety cabinets, and thermocyclers, including Roche thermocyclers.
• Follow GMP, FDA, and internal quality standards for documentation, audit readiness, and document control.
• Collaborate closely with a small shift-based team in an all-hands environment to ensure continuous coverage for samples arriving approximately every 8 hours.
• Review and handle reporting for specialty products as needed, ensuring accurate and timely data entry and communication.

• Experience with PCR or qPCR techniques; 2+ years of PCR or microbiology laboratory experience preferred for Associate QC Analyst level.
• For QC Analyst level: minimum 2+ years of GMP experience required, with 5+ years preferred in molecular pharmaceutical or GMP laboratory settings.
• For Sr QC Analyst level: minimum 5+ years of GMP experience required, with 10+ years preferred in molecular pharmaceutical and GMP environments.
• Hands-on laboratory experience in molecular biology, microbiology, or a closely related discipline.
• Ability to perform RNA extraction from tissue samples and handle biological materials safely.
• Familiarity with quality control testing in a pharmaceutical or GMP environment.
• Experience with laboratory assays, including qPCR and related molecular biology techniques.
• Strong understanding of GMP and FDA-aligned quality expectations, including documentation, audit support, and document control.
• Proficiency with general laboratory practices, including pipetting by hand, reagent preparation, and sample handling.
• Ability to work a consistent third-shift schedule in a 24/7 testing operation.
• Strong attention to detail, accuracy in data recording, and adherence to established methods and protocols.

• Bachelor's degree or higher in Microbiology or a related discipline preferred for all levels.
• High School Diploma or G.E.D. required for all levels.
• Experience in a molecular pharmaceutical or GMP laboratory setting strongly preferred for QC Analyst and Sr QC Analyst levels.
• Familiarity with environmental monitoring and contaminant monitoring in a laboratory setting.
• Experience operating a variety of centrifuges (small to large, including refrigerated models).
• Experience using microbalances, fume hoods, and biosafety cabinets.
• Exposure to or experience with Roche thermocyclers or similar thermocycler platforms.
• Comfort using qPCR software and basic laboratory software systems.

The role is on third shift, Monday through Thursday, working 10-hour days starting at 9:00 p.m. The lab is equipped with a wide range of instruments, including various centrifuges (small to large and refrigerated), microbalances, fume hoods, biosafety cabinets, Roche thermocyclers, liquid handler robots, and qPCR software systems.

This is a Permanent position based out of Madison, WI.

The pay range for this position is $45760.00 - $75000.00/yr. Competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1;
Life and AD&D Insurance, and Short and Long-term Disability;
Health and Flexible Saving Account options;
Employee Assistance Program, generous vacation; paid Holidays; 401k

This is a fully…