Quality Assurance Validation Associate

Role: Quality Assurance Validation Associate responsible for reviewing and approving validation deliverables to ensure compliance with regulatory requirements, internal standards, and industry best practices. Main objectives: Main objectives include providing quality oversight for validation documents related to facilities, utilities, equipment, process qualification, cleaning, QC methods, and computer system validation. Core responsibilities: evaluating validation master plans, qualification protocols, and change controls supporting validation for manufacturing systems and addressing risk assessments and participating in audits Requirements: Bachelor’s in Biotechnology, Microbiology, Pharmacy, or related field minimum 5 years of experience in pharmaceutical/biotech validation proficiency with validation protocols, electronic document systems (e.g., Veeva, Kneat) deep knowledge of GMP/EU regulations and GxP guidelines Preferred qualifications: Preferred qualifications include extensive cross-functional team experience and advanced certifications. High-value specifics: biopharma manufacturing environment validation of facilities and systems GxP compliance involvement in regulated environments experience supporting manufacturing validation projects Location/Work Setup: based in Thousand Oaks, CA, with potential for in-person work in controlled environments. The role may involve working in gowning areas and around chemicals, requiring adherence to safety protocols. #J-18808-Ljbffr Takeda