QC Chemist II: cGMP Testing, Method Dev & QA Impact

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

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.