Quality Control Analyst II

Anika Therapeutics; Bedford (MA); On-site; USD 66,000 - 82,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare

Health savings account

401(k) with company match

Employee stock purchase plan

PTO and long-term incentives

Job summary

Anika Therapeutics is seeking a Quality Control Analyst II in Bedford, MA. You will perform analytical testing of raw materials, in-process materials, finished products, stability samples, and R&D support in a cGMP setting.

You will operate HPLC, GC, GC/MS, UV/Vis and FTIR instruments, maintain GDP-compliant documentation, and collaborate with R&D to develop methods and support validation and transfer activities. A strong attention to detail and regulatory knowledge are essential.

Qualifications

• Bachelor's degree in Chemistry or physical science or equivalent experience.
• 2+ years of analytical testing experience in an FDA-regulated pharmaceutical or medical device environment.
• GMP knowledge and applicable ISO standards.
• Proficiency in HPLC and GC analyses, with method development and validation experience.
• Hands-on experience with UV/Vis and FTIR spectrophotometers, pH meters, and osmometers.
• Experience with titrations and compendial identification testing.

Responsibilities

• Perform analytical testing of incoming raw materials, in-process materials, finished products, stability samples, and R&D samples.
• Operate analytical instrumentation (HPLC, GC, GC/MS, UV/Vis, FTIR, osmometers, pH meters).
• Complete accurate documentation in GDP-compliant records and review others' notebooks.
• Collaborate with R&D to develop test methods and support validation and transfer activities.
• Maintain training and demonstrate proficiency through regular training and instruction.
• Support continuous improvement initiatives in the laboratory.

Skills

Analytical testing

Documentation & accuracy

Regulatory compliance

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in Chemistry or physical science

Tools

HPLC

GC

GC/MS

UV/Vis spectrophotometry

FTIR spectrophotometry

pH meters

Osmometers

Karl Fischer titration

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Control Analyst II

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

3 days ago Requisition ID: 1777

Salary Range: $66,000.00 To $82,000.00 Annually

What You’ll Do

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 elevate 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.