QA Validation Associate

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

Summary:

Will work as part of cross-functional teams providing quality oversight, review, and approval of validation deliverables and change controls to ensure that products and processes meet appropriate regulatory agency validation requirements, internal company standards and current industry practices. This position will focus on disciplines related to facilities, utilities, equipment, instruments, process qualification, cleaning, computer systems validation and data integrity in a supportive capacicity.

Duties and Responsibilities

• Responsible for reviewing validation documents, against Standard Operating Procedures (SOPs) for accuracy and compliance with procedures, based on regulatory requirements and internal guidelines.
• Review from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.
• Responsible for reviewing Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages in accordance with existing procedures. Reviews deliverables for compliance with existing requirements. Approves documentation related to system decommissioning.
• Provide validation expertise and support for the development (or modification phases) of manufacturing facility, utilities, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
• Participate in the risk assessment related to the project.
• Assure requirements traceability throughout the whole project life cycle.
• Provide support in all quality-related issues, including GMP regulations
• Maintain project metrics to communicate risk trends and implementation readiness to support project timelines and commercial readiness
• May perform other duties as assigned.

Education and/or experience

• 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)