QC Lab Manager: Lean, Right-First-Time Analytics

Anika Therapeutics; Bedford (MA); On-site; USD 122,000 - 152,000; Full time

Job summary

Anika Therapeutics in Bedford, MA is seeking a Manager, Quality Control to lead the analytical testing laboratory, ensuring materials, in-process samples, and finished products meet quality and regulatory requirements. You will apply Lean principles, supervise QC chemists, and optimize methods while maintaining data integrity.

The role demands deep analytical chemistry expertise, strong documentation, and experience with CDS and regulatory audits.

Qualifications

• 7+ years in a GMP-analytical QC lab.
• Experience authoring and closing OOS/OOT investigations.
• Lead analytical method validation, verification, and transfer.
• Strong CDS data integrity and audit-trail expertise.
• Proven leadership and mentoring ability.

Responsibilities

• Direct daily QC lab operations to meet Lean targets and KPI goals.
• Oversee data integrity and regulatory compliance for testing results.
• Lead investigations to identify root causes and CAPAs.
• Develop and approve SOPs, test methods, and validation protocols.
• Coordinate audits as a primary host and SME for the lab.

Skills

Analytical chemistry

GMP operations

Lab leadership

Data integrity

Lean principles

OOS/OOT investigations

CAPA management

SOP development

Root-cause analysis

Education

Bachelor's degree in Chemistry

Master’s or Ph.D. in Chemistry

Tools

Chromatography Data Systems (CDS)

UV-Vis spectrophotometers

Rheometers

Titrators (Karl Fischer, potentiometric)

FT-IR spectrometers

TOC analyzers

Job description

Anika Therapeutics in Bedford, MA is seeking a Manager, Quality Control to lead the analytical testing laboratory, ensuring materials, in-process samples, and finished products meet quality and regulatory requirements. You will apply Lean principles, supervise QC chemists, and optimize methods while maintaining data integrity.

The role demands deep analytical chemistry expertise, strong documentation, and experience with CDS and regulatory audits.