QA Validation Specialist

Randstad USA; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Randstad USA is seeking a quality-focused professional to serve as a validation lead, overseeing cross-functional reviews of validation deliverables to ensure regulatory and internal standards are met. The role covers facilities, utilities, equipment, instruments, process qualification, cleaning, computer systems validation, and data integrity.

The position requires a Bachelor’s degree in biotechnology, microbiology, pharmacy or equivalent and at least five years in pharma/biotech validation,

Qualifications

• Bachelor’s Degree in Biotechnology, Microbiology, Pharmacy or equivalent.
• At least 5 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Experience in pharmaceutical/biotech validation which includes the writing and executing of protocols.
• Proficiency in electronic document management systems (e.g. Veeva, Kneat, ALM).

Responsibilities

• Review validation documents against SOPs for accuracy and compliance with procedures, regulatory requirements, and internal guidelines.
• Provide validation expertise and support for development or modification of manufacturing facilities, utilities, systems, processes, and computerized systems; address QA requirements.
• Participate in risk assessment related to the project and ensure traceability throughout the project lifecycle.
• Support QA related issues including GMP regulations and communicate risk trends and readiness for timelines and commercial readiness.

Skills

Quality oversight

Regulatory compliance

Validation review

Document control

Education

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

Tools

Veeva

Kneat

ALM

Job description

Randstad USA is seeking a quality-focused professional to serve as a validation lead, overseeing cross-functional reviews of validation deliverables to ensure regulatory and internal standards are met. The role covers facilities, utilities, equipment, instruments, process qualification, cleaning, computer systems validation, and data integrity.

The position requires a Bachelor’s degree in biotechnology, microbiology, pharmacy or equivalent and at least five years in pharma/biotech validation,