Sr. Quality Assurance Specialist - Data Integrity & Validation Lead

job summary: Join a top-tier pharmaceutical leader in vibrant Bend, Oregon, as a Quality Assurance Systems Specialist / Sr Specialist and DI Lead. In this vital 1-year contract role, you will oversee computer system validation, drive equipment commissioning and qualification, and champion Data Integrity (DI) maturity across site operations.

location: Bend, Oregon job type: Contract salary: $45.00 - 53.08 per hour work hours: 9 to 5 education: Bachelors

responsibilities:

• Lead equipment qualification, commissioning, and Computer System Validation (CSV) projects to ensure compliance with GxP regulations.
• Write, execute, review, and approve validation protocols, lifecycle documents, and quality records.
• Act as site Subject Matter Expert (SME) for Data Integrity, establishing DI forums, GEMBA walkthroughs, and risk remediation plans.
• Collaborate cross-functionally with IT, QC, Automation, QA, and external vendors to evaluate and mitigate DI risks.
• Assist with investigations, root cause analyses, CAPAs, and support regulatory or client inspections.

qualifications:

• Bachelor’s degree in a scientific discipline (minimum).
• 5+ years of pharmaceutical/biotechnology industry experience, including 2+ years in a Quality Unit.
• Hands-on experience with equipment, analytical instrument qualification, and computerized system validation.
• Strong working knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and USP industry standards.

skills: Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Good Documentation Practices (GDP)

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 HRsupport@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.

,

• Lead equipment qualification, commissioning, and Computer System Validation (CSV) projects to ensure compliance with GxP regulations.
• Write, execute, review, and approve validation protocols, lifecycle documents, and quality records.
• Act as site Subject Matter Expert (SME) for Data Integrity, establishing DI forums, GEMBA walkthroughs, and risk remediation plans.
• Collaborate cross-functionally with IT, QC, Automation, QA, and external vendors to evaluate and mitigate DI risks.
• Assist with investigations, root cause analyses, CAPAs, and support regulatory or client inspections.

Good Laboratory Practices (GLP), Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Good Documentation Practices (GDP)