QA Specialist II, Validation, Contractor

Bpc-Jad Group; Waltham (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company is seeking a Specialist II to join their growing QA Validation group for a 6-month contract. The role involves ensuring compliance with GMP regulations, conducting QA oversight for validation activities, and collaborating with various teams. Ideal candidates should hold a technical degree and possess extensive experience in validation and quality assurance.

Qualifications

• 5+ years in validation and/or quality assurance.
• Strong knowledge of 21 CFR, ICH, and EU Regulations.
• Preferred experience in cell and gene therapy manufacturing.

Responsibilities

• Provide QA oversight of CQV activities for cGMP manufacturing.
• Review and approve validation protocols and reports.
• Collaborate with cross-functional teams.

Skills

QA oversight

Validation protocols review

Risk-based decision making

Collaboration

Education

Bachelor’s degree in a technical discipline

Equivalent work experience (7+ years)

Tools

Veeva

Kneat

Job description

We are looking for a contractor as a Specialist II to join their growing QA Validation group. This is expected to be a 6 month contract position. The role is expected to be onsite in Waltham 3-4 days per week.

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 current knowledge of regulatory trends and best practices related to validation.

Requirements:

• 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-months contract