Senior Specialist and Site DI Lead, Quality Assurance

Detailed Job Description:

Title: Senior Specialist and Site DI Lead, Quality Assurance

Location: Bend Oregon 97703

Duration: 12 Months

Pay rate: $53.50/HR on W2 without PTO (Paid time off).

Work authorization: US citizen/GC/EAD

Shift: 1st

Education

• Bachelor’s Degree in science (minimum)

Work 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).

Job Tasks

• 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.