Senior QA Validation Specialist

Randstad USA; Thousand Oaks (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Randstad USA is seeking a Validation Specialist to join cross-functional teams and ensure that validation deliverables meet regulatory requirements, internal standards, and current industry practices. The role covers facilities, utilities, equipment, instruments, process qualification, cleaning, computer systems validation, and data integrity.

The incumbent will review and approve validation documentation, participate in risk assessments, maintain traceability, and support QA issues in a GMP

Qualifications

• Bachelor's degree in Biotechnology, Microbiology, Pharmacy or equivalent.
• At least 5 years of experience in Pharmaceutical/Biopharmaceutical manufacturing or related field.
• Experience in validation writing and execution of protocols.
• Proficiency with electronic document management systems (Veeva, Kneat, ALM).

Responsibilities

• Review validation documents for accuracy and regulatory compliance against SOPs and guidelines.
• Assess validation documentation to support project development and regulatory submissions.
• Review and approve VMP, DQ, IQ, OQ, PQ, CSV, and Validation Maintenance packages.
• Provide validation expertise for manufacturing facilities, utilities, systems, and information and computerized systems.
• Participate in risk assessment and ensure traceability throughout the project lifecycle.
• Support QA-related issues, including GMP regulations, and communicate risks through metrics.

Skills

Quality oversight

Regulatory knowledge

Risk assessment

Traceability

GMP compliance

Documentation review

SOP compliance

CSV

Regulatory submissions

Education

Bachelor's degree in Biotechnology/Microbiology/Pharmacy

Advanced degree

Tools

Veeva

Kneat

ALM

Job description

Randstad USA is seeking a Validation Specialist to join cross-functional teams and ensure that validation deliverables meet regulatory requirements, internal standards, and current industry practices. The role covers facilities, utilities, equipment, instruments, process qualification, cleaning, computer systems validation, and data integrity.

The incumbent will review and approve validation documentation, participate in risk assessments, maintain traceability, and support QA issues in a GMP