Quality Control Analyst

Job Description

Job Description

Quality Control Analyst (PCR) - 3rd shift

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 pancreatin powder and select specialty products, including some heparin 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.
• High School Diploma or G.E.D. required for all levels.
• 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.
• 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., with a third-shift differential of $1.50 per hour. 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. The culture is described as laid back, driven, and hard working, with a "work hard, play hard" mindset.

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 onsite position in Madison,WI.

This position is anticipated to close on Jul 3, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.