Senior Quality Control Analyst

Anika; Bedford (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Discretionary bonus

Comprehensive healthcare

401(k) with company match

Stock purchase plan

Paid time off

Job summary

Anika Therapeutics in the United States is seeking a Senior Quality Control Analyst to lead method development, validation, optimization, and transfer for new materials and finished products in a cGMP environment. You will perform analytical testing and help ensure regulatory compliance while collaborating with QC, R&D, and Technical Transfer teams.

You will prepare documentation for submissions, support product development, and drive improvements in testing reliability and efficiency across

Qualifications

• Bachelor’s degree in Chemistry or equivalent with 7+ years of relevant experience.
• Minimum five years of laboratory experience developing, validating, and performing analytical methods.
• Five+ years of testing experience in an FDA-regulated pharmaceutical or medical device environment.
• Strong knowledge of GMP and ISO standards and analytical method validation requirements.
• Proficiency with HPLC, GC, FTIR, and UV/Vis analysis.

Responsibilities

• 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 HPLC, GC, headspace analysis, moisture analyzers, Karl Fischer titration, UV/Vis and 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 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.

Skills

Analytical method development

Validation and transfer

Regulatory compliance

Lab leadership

Troubleshooting

Education

Bachelor’s degree in Chemistry

7+ years relevant experience

Tools

HPLC

GC

FTIR

UV/Vis

Job description

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.

How You’ll Contribute

• 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.

What It Takes

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 projects while maintaining a high standard of scientific rigor, documentation, and regulatory compliance.

What You Bring

• Bachelor’s degree in Chemistry or another physical science, or 7+ years equivalent relevant experience.
• Minimum of five years of laboratory experience developing, validating, and performing analytical methods.
• Five or more years of testing experience in an FDA-regulated pharmaceutical or medical device environment.
• Demonstrated knowledge of Good Manufacturing Practices (GMP), applicable ISO standards, and analytical method validation requirements.
• Proficiency in HPLC, GC, FTIR, and UV/Vis analytical techniques.
• Demonstrated experience with complex manual and automated testing methods and laboratory equipment.
• Strong working knowledge of wet chemistry techniques, including titrations and compendial identification testing.
• Excellent analytical, problem-solving, and organizational skills, with the ability to manage multiple projects and meet established deadlines.
• Commitment to quality, accuracy, continuous improvement, and achieving performance expectations.
• Ability to work flexible hours as needed to complete laboratory activities and meet business requirements.

Nice to Have

• Experience testing textiles, gels, solids, and liquid suspensions.
• Experience working in a high-volume commercial manufacturing environment.
• Demonstrated ability to balance multiple priorities and consistently meet established deadlines.
• Experience using Microsoft Excel for calculations, data analysis, and graphing operations.

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.