Quality Assurance Validation Contractor

Bpc-Jad Group; Boston (MA); On-site; USD 55,104 - 82,656; Full time

Job summary

Bpc-Jad Group in Boston, MA is seeking Quality Assurance Validation contractors to support CQV activities in a cGMP manufacturing facility and QC laboratories, for a 6 to 12 month onsite engagement.

The role involves reviewing validation protocols and SOPs in Veeva, ensuring data integrity, and collaborating with cross-functional teams to meet regulatory expectations during validation planning and execution.

Qualifications

• Bachelor’s degree in a technical discipline with 5+ years validation experience, or 7+ years equivalent work experience.
• Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5.
• Cell and gene therapy manufacturing experience preferred.
• Contract manufacturing experience preferred.
• Kneat experience strongly preferred.
• Collaborative problem solving and risk-based decision making.
• Team player in large multi-disciplinary projects.

Responsibilities

• Provide QA oversight of CQV activities for a cGMP manufacturing facility and QC laboratories.
• Oversee periodic review and requalification program.
• Review CMMS records related to asset management including asset release, database requests, and work orders.
• Author and review SOPs in Veeva.
• Review and approve validation protocols and reports (IQ, OQ, PQ, CSV, process validation, cleaning validation).
• Ensure compliance of validation activities with GMP regulations, industry guidance, and internal SOPs.
• Collaborate with cross-functional teams 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

Skills

QA validation

Regulatory compliance

GxP

Risk assessment

Documentation

Education

Bachelor’s degree in a technical discipline

7+ years of equivalent work experience

Tools

Kneat

Veeva

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

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 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.

Contract Details

• 6-12 month contract with possible extension.
• Administrative shift.