Lead QA Validation Specialist - CQV & CGMP

ElevateBio; Waltham (MA); On-site; USD 69,000 - 95,000; Full time

Job summary

ElevateBio seeks a Lead QAV Specialist in Waltham to oversee commissioning, qualification, and validation activities from a QA perspective. You will manage CQV-related master plans, assist with risk assessments, deviations, and CAPAs, and lead a team of QA professionals.

Strong regulatory knowledge and GMP experience are required. The role emphasizes collaboration with Engineering, Lab, and Site Services, with potential Kneat system administration and continual process improvement across CQV

Qualifications

• Bachelor’s degree or higher with related experience; master or PhD acceptable with applicable experience.

Responsibilities

• Lead QA partnership for operational activities for Engineering groups (commissioning, qualification, and validation) for GMP facilities and labs.
• Oversee QA events for validation and engineering operations (equipment upgrades, deviations, CAPAs).
• Evaluate CQV change controls by authoring impact assessments and provide QA support and approval.
• Oversee CMMS quality impact assessments with Engineering and Lab teams.
• Coordinate with project teams to develop project schedules, elevate issues, and track milestones.
• Provide administration support for Kneat electronic validation system as needed.
• Lead periodic review and requalification activities in QA for CQV.
• Manage QA QAV personnel including FTEs and contractors.
• Act as QA SME for Equipment Relocation programs during ongoing manufacturing needs.

Skills

CQV oversight

Quality Assurance

Regulatory compliance

Project coordination

Education

Bachelor’s degree in related field

Tools

Kneat

Veeva

Blue Mountain CMMS

Word

Excel

PowerPoint

Job description

ElevateBio seeks a Lead QAV Specialist in Waltham to oversee commissioning, qualification, and validation activities from a QA perspective. You will manage CQV-related master plans, assist with risk assessments, deviations, and CAPAs, and lead a team of QA professionals.

Strong regulatory knowledge and GMP experience are required. The role emphasizes collaboration with Engineering, Lab, and Site Services, with potential Kneat system administration and continual process improvement across CQV