Senior Quality Control Analyst

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Quality Control - Chemistry Regular Full-Time Bedford, MA, Bedford, MA, US

3 days ago Requisition

Salary Range: $84,000.00 To $ Annually

As a Senior Quality Control Analyst
, you’ll play a key role in ensuring product quality, analytical method reliability, and regulatory compliance at Anika Therapeutics. You’ll lead method development, validation, optimization, and transfer activities for new raw materials, intermediates, and finished products while performing analytical testing in a current Good Manufacturing Practice (cGMP) environment.

Working closely with Quality Control, Research and Development (R&D), and Technical Transfer teams, you’ll help ensure analytical methods are successfully implemented during product scale-up and meet applicable regulatory requirements. You’ll also prepare technical documentation to support regulatory submissions, contribute to product development initiatives, and help maintain the quality standards essential to our business.

This role is ideal for an experienced analytical chemistry professional who enjoys solving complex technical challenges, managing multiple projects, and supporting the development and commercialization of innovative products.

• Coordinate with Technical Transfer during product scale-up to ensure analytical testing methods are successfully transferred and implemented in accordance with ICH Q2 guidelines and other applicable method validation requirements.
• Develop, validate, qualify, optimize, and transfer analytical methods for new raw materials, intermediates, finished products, and method improvements.
• Collaborate with R&D to develop analytical test methods for new products and support product development activities.
• Prepare technical reports supporting regulatory submissions, including method development and validation reports, analytical testing results, and product stability data.
• Perform analytical chemistry testing using High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), headspace analysis, moisture analyzers, Karl Fischer titration, UV/Vis and Fourier Transform Infrared (FTIR) spectrophotometry, and osmometric equipment.
• Conduct testing of in-process, stability, Engineering, and R&D samples using established analytical and physicochemical methods.
• Ensure accurate and timely laboratory documentation in accordance with Good Documentation Practices (GDP), review laboratory notebooks, and verify results generated by other analysts.
• Research and optimize analytical methods using accepted industry practices to improve testing reliability, efficiency, and consistency.
• Identify and report procedural deviations and nonconformances, conduct assigned investigations, and support corrective actions through closure.
• Maintain current training and demonstrate proficiency in assigned procedures through documented training, skills development, and classroom instruction as applicable.
• Perform routine maintenance of general laboratory equipment to support reliable laboratory operations.
• Participate in cross-functional projects and initiatives that support business growth, operational effectiveness, and continuous improvement while maintaining cost discipline.

You are an experienced analytical chemistry professional with strong technical expertise in method development, validation, and transfer. You are comfortable troubleshooting complex analytical challenges, evaluating variable data, and exercising sound judgment within established procedures and quality systems. You can manage multiple priorities and…