Quality Control Analyst
Job in
Madison, Dane County, Wisconsin, 53786, USA
Listed on 2026-06-22
Listing for:
Actalent
Full Time
position Listed on 2026-06-22
Job specializations:
-
Quality Assurance - QA/QC
Job Description & How to Apply Below
Job Description
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.
+ 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.
Essential Skills
+
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.
Additional
Skills & Qualifications
+ 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.
Work Environment
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.
Job Type & Location
This is a Permanent position based out of Madison, WI.
Pay and Benefits
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…
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