QC Lab Manager: Lean, Right‑First‑Time Quality Leader

Anika; Bedford (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Anika is seeking a Manager of Quality Control to lead the analytical testing laboratory, ensuring data integrity and regulatory compliance. You will apply Lean principles to improve throughput and lead a team of QC chemists and technicians.

You will oversee instrumentation, audits, and validation/transfer activities, guiding continuous improvement and ensuring right-first-time testing across raw materials, in-process samples, and finished products.

Qualifications

• Bachelor’s degree in Chemistry or related science; 7+ years GMP QC experience.
• 3+ years of progressive supervisory/management experience.
• Experience authoring/closing OOS and OOT investigations.
• Experience supporting analytical method validation/transfer in regulated environments.
• Strong CDS data integrity, audit trail, and user-access controls.

Responsibilities

• Lead daily lab operations applying Lean principles to maximize throughput.
• Establish and monitor KPIs: RFT, TAT, and OEE.
• Oversee instrument maintenance, qualification, and troubleshooting.
• Review and approve complex analytical data per regulations and QA standards.
• Lead investigations using root-cause analysis and drive CAPAs.

Skills

GMP QC testing

Supervisory experience

Analytical method validation

CDS data integrity

Lean principles

Root-cause analysis

Data integrity

Audit readiness

OOS/OOT investigations

Technical writing

Education

Bachelor's degree in Chemistry

Master’s or Ph.D. in Chemistry

Tools

Chromatography Data Systems (CDS)

Job description

Anika is seeking a Manager of Quality Control to lead the analytical testing laboratory, ensuring data integrity and regulatory compliance. You will apply Lean principles to improve throughput and lead a team of QC chemists and technicians.

You will oversee instrumentation, audits, and validation/transfer activities, guiding continuous improvement and ensuring right-first-time testing across raw materials, in-process samples, and finished products.