Job Title: Quality Assurance Systems Specialist
Location: Bend, OR Duration: 12 MonthsWork Experience
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).
Education: Bachelor's degree in science (minimum)
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.
- Level Of Authority : 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.
Environmental/Physical Demands:
Personal Protection Equipment.
Occasional light lifting, less than 25 lbs.
Travel as needed.
