Senior QC Analyst – Method Development & Validation (GMP)

Anika Therapeutics; Bedford (MA); On-site; USD 84,000 - 105,000; Full time

Benefits offered by this job

Discretionary bonus

Comprehensive healthcare

Health savings account

401(k) with up to 5% company match

Employee stock purchase plan

Paid time off

Long-term incentives

Job summary

Anika Therapeutics in Bedford, MA is seeking a Senior Quality Control Analyst to lead analytical method development, validation, and transfer in a cGMP environment. You will collaborate with QC, R&D, and Tech Transfer to ensure methods are robust during scale-up and regulatory submissions.

The role requires experience with HPLC, GC, FTIR, UV/Vis, and method validation, along with strong documentation and problem-solving skills to support product development and continuous improvement.

Qualifications

• Bachelor’s degree or 7+ years of relevant experience.
• 5+ years laboratory experience developing/validating/performing analytical methods.
• 5+ years testing in FDA-regulated pharma/medical device environment.
• Knowledge of GMP, ISO standards and validation requirements.
• Proficient in HPLC, GC, FTIR, UV/Vis techniques.
• Experience with complex manual and automated testing methods.
• Strong analytical, problem-solving and organizational skills.
• Flexible hours to support laboratory activities.

Responsibilities

• Coordinate transfer of analytical methods during scale-up per ICH Q2 guidelines.
• Develop, validate, qualify, optimize, and transfer analytical methods.
• Collaborate with R&D to develop methods for new products.
• Prepare technical reports for regulatory submissions and stability data.
• Perform analytical testing using HPLC, GC, UV/Vis, FTIR, and related equipment.
• Maintain GDP-compliant laboratory documentation and review notebooks.
• Identify deviations, investigations, and corrective actions; track closures.
• Maintain training and operation of laboratory equipment.

Skills

Analytical method development

Validation & transfer

Regulatory compliance

Analytical problem solving

Project management

Documentation & GDP

Education

Bachelor’s degree in Chemistry or physical science

7+ years equivalent experience

Tools

HPLC

GC

FTIR

UV/Vis

Karl Fischer titration

Moisture analyzers

Job description

Anika Therapeutics in Bedford, MA is seeking a Senior Quality Control Analyst to lead analytical method development, validation, and transfer in a cGMP environment. You will collaborate with QC, R&D, and Tech Transfer to ensure methods are robust during scale-up and regulatory submissions.

The role requires experience with HPLC, GC, FTIR, UV/Vis, and method validation, along with strong documentation and problem-solving skills to support product development and continuous improvement.