Senior QA Lead: QC Equipment & CQV Oversight

Career Soft Solutions Inc; Norwood (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Moderna Norwood, MA is seeking a Senior Specialist, Quality Assurance for Quality Control. You will provide quality oversight for QC equipment moves, qualification activities, and decommissioning across Norwood sites, supporting QC lab instrument activities.

Responsibilities include reviewing QC documentation, ensuring data integrity, following GxP guidelines, SOPs, and training, and handling deviations, change controls, and documentation. FDA/ICH knowledge is preferred.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field
• 3–8 years experience in CQV activities within biotech/pharma or regulated GMP environments
• Familiarity with QC equipment qualification/CQV activities and good documentation practices

Responsibilities

• Review and approve QC equipment documentation (qualification/validation protocols, reports, forms, data tables) to ensure readiness and data integrity
• Review QC logbooks and ensure compliance with GxP regulations and company policies
• Identify, review, and approve deviations, change controls, CAPAs, and other QC-related documents
• Ensure data integrity and proper documentation; follow SOPs and training requirements
• Support QC instrument activities and ensure compliance with regulatory requirements

Skills

Quality Assurance

CQV

GxP

Data Integrity

Deviation management

Change control

Documentation

Education

Bachelor's Degree

Tools

Kneat

Microsoft Office

Statistical software

Job description

Moderna Norwood, MA is seeking a Senior Specialist, Quality Assurance for Quality Control. You will provide quality oversight for QC equipment moves, qualification activities, and decommissioning across Norwood sites, supporting QC lab instrument activities.

Responsibilities include reviewing QC documentation, ensuring data integrity, following GxP guidelines, SOPs, and training, and handling deviations, change controls, and documentation. FDA/ICH knowledge is preferred.