QA Validation Specialist II

Job Title:-QA Validation Specialist II

Job Location:- Waltham MA (Hybrid)

Long Term Contract

Client is 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, MA 3-4 days per week.

Here's What You'll Do:

• 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.

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.
• Prior experience working with contract manufacturing preferred.
• Experience with Kneat strongly preferred.