Overview:
Our client is a successful and established company in Bend, OR that specializes in preparing clinical supplies of novel drug formulations using enabling new technologies in a cGMP quality environment.
Responsibilities:
• Knowledge of QA/QC for clinical trials materials and GMP regulations (FDA, EMEA, etc.)
• QA point of contact for external clients, project teams, customer notification, etc.
• Support implementation and continuous improvement of Quality Systems
• Conduct/participate in internal and external quality audits and regulatory inspections
• Controlled document and record review and approval, e.g. SOP, Validation, MBR, analytical test records, batch records, with emphasis on analytical methods, method validation and data review
• Assist with investigations, root cause analysis and corrective and preventive action, as needed
• Coordinate and collate site quality metrics and participate in reporting to upper management
• Controlled documents and records review and approval
• External and internal audit lead
• Flexible work schedule
• Travel as needed
Required Qualifications:
• BS in Science
• Minimum 5 years work experience in pharmaceutical or related industry preferred
• Analytical Quality Assurance experience highly desirable
• Independent and flexible worker that can readily adapt to changing priorities in a fast-paced cutting edge environment
• Support an environment of teamwork and staff development and learning
• Demonstrated attention to detail and excellent oral and written communication skills
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