Quality Assurance Validation Contractor

Full-time Management & Operations

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 va...