Onsite QA Validation Contractor - Boston (6-12 mo)

BioPharma Consulting JAD Group; Boston, Northern (MA, KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

BioPharma Consulting JAD Group seeks Quality Assurance Validation contractors for its Boston, MA team. Positions are 6 to 12 months and are expected to be onsite in Boston, MA, with responsibilities spanning CQV activities, qualification review, and SOP authoring in Veeva.

The role requires a technical degree with 5+ years of validation/QA experience (or 7+ years without a degree) and familiarity with GMP regulations, risk-based validation, and cross-functional collaboration across Validation,

Qualifications

• Bachelor’s degree in a technical discipline with 5+ years validation and/or quality assurance experience.
• In lieu of degree, 7+ years of equivalent work experience.
• Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation.
• Prior experience working in cell and gene therapy manufacturing preferred.

Responsibilities

• Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories.
• Provide QA oversight for periodic review and requalification program.
• Review CMMS records related to asset management including asset release, database requests, and work orders.

Skills

GMP knowledge

Regulatory compliance

Risk-based decision making

Team collaboration

Data integrity

Education

Bachelor’s degree in a technical discipline

Tools

Kneat

Veeva

CMMS systems

Job description

BioPharma Consulting JAD Group seeks Quality Assurance Validation contractors for its Boston, MA team. Positions are 6 to 12 months and are expected to be onsite in Boston, MA, with responsibilities spanning CQV activities, qualification review, and SOP authoring in Veeva.

The role requires a technical degree with 5+ years of validation/QA experience (or 7+ years without a degree) and familiarity with GMP regulations, risk-based validation, and cross-functional collaboration across Validation,