QA Validation Associate

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

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 typically focus on disciplines related to facilities, utilities, equipment, instruments, process qualification, cleaning, computer systems validation and data integrity.

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)