Quality Assurance Validation Specialist (GMP/CSV)

Regulatory Jobs; Thousand Oaks (CA); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda in Thousand Oaks, CA is seeking a Quality Assurance Validation Associate to ensure regulatory validation requirements are met across facilities and systems. You will review validation documents, master plans, IQ/OQ/PQ/CSV, and change controls while supporting regulatory submissions and audits.

Responsibilities include risk assessment, traceability, and guiding QA processes in line with GMP/GxP standards. Local gowning, PPE, and other controlled-environment requirements apply as needed.

Qualifications

• Bachelor’s Degree in Biotechnology, Microbiology, Pharmacy or equivalent.
• Minimum 5 years in pharmaceutical/biopharmaceutical validation.
• Experience writing and executing validation protocols.

Responsibilities

• Review validation documents for accuracy and regulatory compliance.
• Review Validation Master Plans and IQ/OQ/PQ/CSV packages.
• Provide QA support for facility, utilities, systems, process, and computer systems validation.

Skills

GxP knowledge

Cross-functional teamwork

Regulatory compliance

Education

Bachelor’s degree in Biotechnology, Microbiology, Pharmacy or equivalent

Advanced degree (preferred)

Tools

Veeva

Kneat

ALM

Job description

Takeda in Thousand Oaks, CA is seeking a Quality Assurance Validation Associate to ensure regulatory validation requirements are met across facilities and systems. You will review validation documents, master plans, IQ/OQ/PQ/CSV, and change controls while supporting regulatory submissions and audits.

Responsibilities include risk assessment, traceability, and guiding QA processes in line with GMP/GxP standards. Local gowning, PPE, and other controlled-environment requirements apply as needed.