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Quality Control Analyst II

Anika Corporation

Quality Control Analyst IIAs a Quality Control Analyst II, you’ll play an important role in ensuring the quality, consistency, and compliance of materials and products at Anika Therapeutics. You’ll perform analytical testing of incoming raw materials, in-process materials, finished products, stability samples, and samples supporting Engineering and Research and Development (R&D) activities in a current Good Manufacturing Practice (cGMP) environment.Working with established procedures and collaborating with colleagues across Quality Control, Manufacturing, Engineering, and R&D, you’ll help ensure reliable test results, support product development, and maintain the high quality standards required in a regulated medical device and pharmaceutical environment.This role offers the opportunity to apply your analytical chemistry expertise, contribute to method development and validation, and help drive continuous improvement in laboratory operations and product quality.Perform incoming raw material testing in accordance with applicable United States Pharmacopeia (USP), European Pharmacopoeia (EP), and American Chemical Society (ACS) reagent specifications.Conduct analytical chemistry testing of in-process, manufacturing release, stability, Engineering, and R&D samples using established methods and procedures.Operate analytical laboratory instrumentation, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Gas Chromatography-Mass Spectrometry (GC/MS), headspace analysis, moisture analyzers, and Karl Fischer titration systems.Perform testing using UV/Vis and Fourier Transform Infrared (FTIR) spectrophotometers, automated and manual titration systems, freezing point and vapor pressure osmometers, Brookfield cone-and-plate viscometers, Ubbelohde tube and dilute solution viscometers, pH meters, Total Organic Carbon (TOC) analyzers, and conductivity meters.Complete accurate and timely laboratory documentation in accordance with Good Documentation Practices (GDP), review laboratory notebooks, and verify results generated by other analysts.Collaborate with R&D to develop test methods for new products and support method qualification, validation, optimization, and transfer activities.Research and optimize analytical methods using accepted industry practices to support reliable, consistent, and compliant testing.Identify and report procedural deviations and nonconformances, participate in assigned investigations, and support corrective actions through closure.Maintain required training and demonstrate proficiency in assigned procedures through documented training, skills development, and classroom instruction as applicable.Perform routine maintenance of general laboratory equipment and contribute to other laboratory projects and continuous improvement initiatives as assigned.You are a detail-oriented analytical professional who understands the importance of accuracy, documentation, and compliance in a regulated laboratory environment. You approach testing and troubleshooting methodically, use sound judgment when evaluating results, and know when to escalate unexpected findings or procedural issues. You work effectively with cross-functional colleagues, manage competing priorities, and remain focused on meeting quality standards and established deadlines.Bachelor’s degree in Chemistry, another physical science, or equivalent experience.2+ years of analytical testing experience in an FDA-regulated pharmaceutical or medical device environment.Demonstrated knowledge of Good Manufacturing Practices (GMP) and applicable ISO standards.Proficiency in HPLC and GC analyses, with experience in analytical method development and validation.Hands-on experience with basic laboratory instrumentation, including UV/Vis and FTIR spectrophotometers, pH meters, and osmometers.Experience with wet chemistry techniques, including titrations and compendial identification testing.Strong attention to detail and a commitment to accurate documentation and reliable test results.Ability to work flexible hours as needed to complete laboratory activities and meet business requirements.Experience with viscometers, GC/MS, TOC analyzers, conductivity meters, or additional analytical laboratory instrumentation.Experience working in a collaborative, results-driven team environment.Ability to manage multiple priorities and consistently meet established deadlines.Experience maintaining spreadsheets and preparing basic graphs to support laboratory data review and analysis.

Vacancy posted 2 days ago
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