Senior QA Specialist, QC Lab Equipment & Compliance

Career Soft Solutions Inc; Norwood (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Moderna Norwood seeks a Senior Specialist, Quality Assurance for Quality Control to provide quality oversight for QC equipment moves, qualification, and decommissioning activities across Norwood sites. You will join the QA for QC team to uphold GxP and GMP standards in laboratory environments.

You will review documentation, ensure data integrity, and drive compliance with SOPs, CAPAs and change controls. Strong background in CQV and QC testing is essential.

Qualifications

• Bachelor’s degree in biology, microbiology, chemistry, biochemistry, engineering or related field.
• 3–8 years’ experience in CQV activities within a regulated GMP environment.
• Knowledge of FDA/EU/ICH guidelines and QC equipment qualification.
• Familiarity with deviation management, change control and data integrity.

Responsibilities

• Review and approve QC equipment qualification/validation documents.
• Ensure data integrity, regulatory compliance and audit readiness.
• Follow SOPs and work instructions in QA for QC activities.
• Identify, review and approve deviations, change controls and CAPAs.
• Support inspections and maintain GxP documentation.

Skills

GxP compliance

Quality oversight

Data integrity

Documentation

Deviation management

Change control

CQV (qualification/validation)

Education

Bachelor’s degree in biology/chemistry/engineering

Tools

Kneat

Microsoft Office

Statistical software

Job description

Moderna Norwood seeks a Senior Specialist, Quality Assurance for Quality Control to provide quality oversight for QC equipment moves, qualification, and decommissioning activities across Norwood sites. You will join the QA for QC team to uphold GxP and GMP standards in laboratory environments.

You will review documentation, ensure data integrity, and drive compliance with SOPs, CAPAs and change controls. Strong background in CQV and QC testing is essential.