Quality Assurance Validation Contractor

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

We are looking for Quality Assurance Validation contractors to join our growing QA Validation group in Boston MA. Positions range from 6 to 12 months. The roles are expected to be onsite in Boston, MA.

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.
• Perform review of CMMS records related to asset management including asset release, database requests, and work orders.
• Author and perform review of SOPs in Veeva.

• Review and approve validation protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation).
• Ensure compliance of validation activities with applicable GMP regulations, industry guidance, and internal SOPs.
• Collaborate with cross-functional teams (Validation, QA, Engineering, Manufacturing, QC) to support timely execution of validation projects.
• Participate in change control assessments, risk assessments, and deviation investigations related to validation.
• Provide QA input during validation planning and execution phases.
• Support audits and regulatory inspections by providing validation documentation and addressing QA-related inquiries.
• Ensure data integrity and documentation accuracy in all validation records.
• Maintain cu

• 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 is required.

• Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation.
• Prior experience working in cell and gene therapy manufacturing preferred.
• Prior experience working with contract manufacturing preferred.
• Experience with Kneat strongly preferred.
• Applies collaborative approach to problem solving and is experienced with risk-based decision making.
• Team player who works well in large multi-disciplinary project groups by listening effectively and inviting open discussion.

• 6-12 month contract with possible extension
• administrative shift