Quality Control Analyst

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 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…