QA Systems Specialist

Onsite: Bend, OR

Job Description

• 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).
• 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.
• 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.
• Personal Protection Equipment.
• Occasional light lifting, less than 25 lbs.
• Travel as needed

Education

• Bachelor’s Degree in science (minimum)

The hiring range for this position is $45 to $50.51per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.