QC Analyst II - GMP Testing & Method Dev (Flexible)

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

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