Quality Assurance Systems Specialist

Position Title: Quality Assurance Systems Specialist

Work Location: Bend, OR 97703

Assignment Duration: 12 months

Work Arrangement: Onsite

Key Responsibilities:

• Support commissioning and qualification and computer system validation projects.

• Write, Execute, Review and Approve validation protocols, reports, and system lifecycle documents, as required.

• Collaborate across functions, including IT, QC, Automation, QA, and Vendors, as required, to review and approve qualifications and validations.

• Perform assessments as part of change and risk management.

• Act as subject matter expert and ensure consistency in validation strategy/approach for equipment, systems, computers, and methods.

• Support trouble shooting of systems and staff training, as required.

• Participate in client and regulatory inspections.

• Assist with investigations, root cause analysis, and corrective and preventative action, as needed.

• Enhance the promotion of Data Integrity (DI) culture and raise DI awareness across the site.

• Improve site DI maturity as defined.

• Establish and facilitate site DI forum including a consistent and structured agenda but not limited to: Ongoing DI activities (remediation CAPAs, trainings); Sharing from Global (best practice, case study, any other DI updates/requirements); Sharing from Site (best practice, case study, deviations with potential DI impact, etc.); Ad hoc topics (e.g. Inspection preparation).

• Establish regular DI GEMBA walkthrough.

Qualification & Experience:

• Bachelor’s Degree in science (minimum)

• Minimum five years experience in pharmaceutical / biotechnology or related industry, including two years in quality unit.

• Experience with equipment & analytical instrument qualification and computerized systems validation.

• Working knowledge of GxPs, Regulations (such as 21 CFR Part 11 & Annex 11), and related industry standards (e.g. USP).

• Controlled documents and records generation, review, and approval.

• Supervise conduct of validation activities and advise on course of action for problem resolution.

• Make decisions related to system commissioning, qualification, and validation activities.

• Work with stakeholders to resolve and reduce potential DI risk from findings, and gap assessments.

Working Conditions & Physical Demands (If Applicable):

• Personal Protection Equipment.

• Occasional light lifting, less than 25 lbs.

• Travel as needed.

Additional Information (If Applicable):

This job description is intended to provide a general overview of responsibilities and duties. Additional responsibilities and duties may be performed with appropriate documentation and approval.

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