On-Site Validation & Data Integrity Specialist

Jubilant HollisterStier LLC; Spokane (WA); On-site; USD 80,469 - 90,000; Full time

Job summary

Jubilant HollisterStier LLC in Spokane, WA is seeking a seasoned professional to oversee computerized system validation and data integrity at the JHS-Spokane site. You will conduct periodic reviews, author qualification documents, and manage change control for production systems, ensuring compliance during audits.

Candidates should have 5+ years of relevant experience with a BS degree (or 10+ years without one) and strong writing, validation, and QA background.

Qualifications

• Minimum 5 years related experience with BS degree or 10 years of experience without BS degree.
• Experience with technical writing, building and manufacturing computer control processes/systems.
• QA operation systems and validation experience required.
• GAMP 5 Certification strongly preferred.
• Experience with Data Integrity, Computer Software Validation, GMP records storage and SAP preferred.

Responsibilities

• Perform periodic reviews and audit trail reviews of computerized systems.
• Write and review documents to support the qualification of a computerized system, including: Validation Plan, User Requirements Specification, Risk Assessment, Traceability Matrix, Qualification Protocol, Qualification Test Plan, Qualification Acceptance Report, Validation Plan Acceptance Report.
• Write and manage change control documents for computerized systems and assist with change controls for production computerized systems as necessary.
• Write and review CSV SOPs.
• Partner with other departments to ensure the site is compliant.
• Provide support for computerized systems during audits, deviations, and investigations.

Skills

Technical writing

Data integrity

Validation

GAMP 5

Education

BS degree

Tools

SAP

Job description

Jubilant HollisterStier LLC in Spokane, WA is seeking a seasoned professional to oversee computerized system validation and data integrity at the JHS-Spokane site. You will conduct periodic reviews, author qualification documents, and manage change control for production systems, ensuring compliance during audits.

Candidates should have 5+ years of relevant experience with a BS degree (or 10+ years without one) and strong writing, validation, and QA background.