Qualiy Validation Associate

As a Qualiy Validation Associate you 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.

salary: $60 - $74.2 per hour
shift: First
work hours: 8 AM - 4 PM
education: Bachelors

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.

The essential functions of this role include:

• working in a smoke free environment
• wearing steel toe shoes

Skills

• Quality Assurance
• Quality Control
• SOP
• GMP
• Validations
• Technical writing
• Veeva

Qualifications

• Years of experience: 5 years
• Experience level: Experienced

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.


Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.