Quality Assurance Validation Contractor

BioPharma Consulting JAD Group; Boston (MA); On-site; USD 83,000 - 152,000; Full time

Job summary

BioPharma Consulting JAD Group in Boston, MA seeks Quality Assurance Validation contractors to join our growing QA Validation group. Positions range from 6 to 12 months and are expected to be onsite in Boston, MA.

Responsibilities include QA oversight of CQV activities, review of validation protocols (IQ, OQ, PQ, CSV, process validation, cleaning validation), ensuring GMP compliance, collaborating with cross-functional teams, change control, risk assessments, and supporting audits with

Qualifications

• Bachelor's degree in a technical discipline; 5+ years validation/QA experience; in lieu of degree, 7+ years experience.
• Experience with cGMP manufacturing and QC laboratories.
• Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation.

Responsibilities

• Provide QA oversight of CQV activities for the cGMP manufacturing facility and QC laboratories.
• Oversee periodic review and requalification programs.
• Review CMMS records related to asset management and work orders.

Skills

QA Validation

cGMP

Cross-functional collaboration

Regulatory compliance

Documentation

Data integrity

Risk assessment

Education

Bachelor's degree in a technical discipline

7+ years equivalent experience in lieu of degree

Tools

Kneat

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