Quality Control Analyst II

Anika; Bedford (MA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

Health savings account

401(k) with company match

Employee stock purchase plan

Paid time off

Long-term incentives including stock

Stock awards

Job summary

Anika Therapeutics in Bedford, MA is seeking a Quality Control Analyst II to ensure materials and products meet strict quality and regulatory standards. You will perform analytical testing across raw materials, in-process and finished products within a cGMP environment, collaborating with QC, Manufacturing, Engineering, and R&D teams.

You’ll develop and validate analytical methods, maintain rigorous documentation, and support continuous improvement initiatives while adhering to GDP and safety

Qualifications

• Bachelor’s degree in Chemistry or related field.
• 2+ years of analytical testing experience in FDA-regulated pharma/medical device environments.
• Knowledge of GMP and ISO standards.
• Proficiency with HPLC and GC analyses, including method development/validation.
• Hands-on use of UV/Vis and FTIR spectrophotometers, pH meters, and osmometers.

Responsibilities

• Perform incoming raw material testing per USP/EP/ACS specs.
• Conduct analytical testing of in-process, release, stability, and R&D samples.
• Operate HPLC/GC/GC-MS, UV/Vis, FTIR, titration, osmometers, and other lab instruments.
• Maintain GDP-compliant documentation and review notebooks.
• Collaborate with R&D to develop/test methods and support validations.
• Identify deviations and participate in investigations and corrective actions.
• Maintain equipment and contribute to continuous improvement initiatives.

Skills

HPLC

GC

UV/Vis

FTIR

pH meters

Osmometers

wet chemistry

GDP documentation

GMP knowledge

Education

Bachelor’s degree in Chemistry or related field

Tools

HPLC systems

GC systems

GC/MS

FTIR spectrometer

TOC analyzers

viscometers

pH meters

Job description

As 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.

How You’ll Contribute

• 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.

What It Takes

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 lift 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.

What You Bring

• 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.

Nice to Have

• 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.

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.