QA Specialist II, Validation, Contractor

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