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.
The Quality Control Laboratory Analyst performs routine analytical testing, precise documentation, and reporting for pharmaceutical drug substances and drug products in a compliant GMP laboratory environment. Responsible for executing assays such as dissolution, content uniformity, and identity testing, this role plays a key part in maintaining product quality and operational efficiency. Additionally, the role supports continuous improvement initiatives, participates in daily tier meetings, and assists with laboratory investigations, instrument troubleshooting, and technical documentation. Responsibilities Perform routine laboratory analytical testing on pharmaceutical drug products and drug substances, including dissolution, assay/degradate, content uniformity, and identity testing in a GMP laboratory. Execute accurate documentation and reporting of all testing results in full compliance with regulatory, cGLP, and cGMP guidelines. Conduct simple troubleshooting of analytical laboratory instrumentation to ensure continuous operational readiness. Participate actively in laboratory investigations and root cause analysis for out-of-specification or anomalous results. Engage in daily tier process meetings to review operational targets, quality metrics, and lab performance. Apply continuous improvement principles (e.g., 5S, Kaizen, Hoshin, Standard Work) to enhance laboratory efficiency and workflows. Assist with technical writing, including updating standard operating procedures (SOPs) and drafting quality notifications. Education Bachelor of Science (B.S.) degree in Chemistry, Biology, Engineering, or a related STEM field. Experience Working knowledge of routine laboratory equipment operations, such as Karl Fischer, pH meters, conductivity meters, UV-Vis, HPLC, and dissolution apparatus. Core understanding of regulatory compliance, cGLP principles, and cGMP standards within a pharmaceutical environment. Proficiency in Microsoft Office applications (Word, Excel, Outlook). Preferred hands-on experience operating advanced instrumentation, including HPLC, dissolution apparatus, FTIR, and NIR. Preferred experience utilizing chromatography data systems (Empower) and Laboratory Information Management Systems (Labware/LIMS). Preferred background in executing root cause analysis, technical writing, continuous improvement methodologies, and participating in Tier management processes.
Additional Information Compliance Standards:
Operating strictly within cGMP and cGLP framework to ensure regulatory audit readiness.
Continuous Improvement Focus:
Utilizes Lean/CI frameworks like 5S, Kaizen, and Standard Work to optimize daily analytical testing operations.
