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QC Analyst 1
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Based on New Hampshire data
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$59,711 / year median in New Hampshire
-14% projected decline
Job Description
QC Analyst 1 Lonza is seeking a QC Analyst 1 to support quality control testing for biopharmaceutical products in a regulated GMP environment. In this role, you will perform routine and specialized analytical assays (e.g., HPLC, ELISA, PCR) on in-process, release, and stability samples, ensuring data integrity and compliance with SOPs, cGMP, and regulatory requirements. You will maintain instruments, troubleshoot basic issues, document results in LIMS and lab notebooks, and assist with investigations, deviations, and CAPAs. Collaboration with manufacturing, QA, and development teams is key as you help deliver safe, effective therapies to patients worldwide. Perform routine and specialized analytical testing on biopharmaceutical samples (in-process, release, stability) Operate, maintain, and perform basic troubleshooting on analytical instruments (e.g., HPLC, ELISA, PCR) Document all testing activities and results accurately in LIMS and laboratory notebooks per cGMP and SOPs Review data for accuracy, completeness, and compliance with regulatory and internal quality requirements Support deviation investigations, out-of-specification results, and implementation of CAPAs Assist with method transfers, qualifications, and improvements under guidance from senior staff Follow all safety protocols, good laboratory practices, and data integrity standards Collaborate with manufacturing, QA, and development teams to ensure timely sample testing and release Participate in training, continuous improvement activities, and audit preparation/readiness Maintain inventory of lab reagents, consumables, and ensure proper sample handling and storage GMP compliance Good Laboratory Practice (GLP) HPLC operation and analysis ELISA techniques PCR and molecular assays LIMS or electronic data systems Data analysis and documentation Laboratory equipment maintenance Deviations and CAPA support Aseptic and safe lab practices Medical Insurance Dental Insurance Vision Insurance Life Insurance 401k Familiarity with cGMP and FDA/ICH guidelines for biopharmaceutical manufacturing Hands-on experience with analytical methods such as HPLC, ELISA, or PCR in a lab setting Training in Good Laboratory Practices (GLP) and data integrity principles Prior internship or co-op in biopharma, QC, or analytical laboratory preferred Ability to work in a regulated, documentation-intensive environment