Sequoia is seeking a Quality Auditor to help administrate, manage, and conduct various types of quality systems, cGMP, supplier, and vendor audits as part of our Quality services offerings and to meet the needs of our clients.

Responsibilities

• Adhere to Sequoia and/or client requirements for established audit processes, tools and interactions, when applicable
• Develop and/or confirm audit agendas based on types of audits with reference to a myriad of quality standards and guidances (for example, 21 CFR 211, 21 CFR 820, ISO 13485, etc.)
• Review prior audit packets for historical findings, audit posture and new audit requests in preparation for audit development
• Author factual audit observations with reference to standards and guidances and industry expectations
• Discern level of audit deficiency category for assignment of observations (for example Critical, Major, Minor and General for Recommendation)
• Partner with clients and vendors to ensure audit logistics, agenda, scheduling and conduct of audit are defined and completed
• Ensure interactions with clients and vendors is professional and that findings are communicated in a factual manner
• Ensure timely completion of audit actions in coordination and agreement with Sequoia, vendors and clients including contacting clients, scheduling of audits, authoring of reports, feedback, revision and updates for final signature/approval of audit reports
• Ensure appropriate and open communication with Sequoia, Audit Project Leads, clients and vendors for visibility and timely escalation or response
• Review and confirm appropriate Corrective and Preventive Actions (CAPA) are developed by clients as applicable
• Follow up and review completeness, closure, and effectiveness of CAPAs as applicable
• Travel to and from the audit site required (as applicable)

Qualifications

• Bachelor's degree within a life science or related field required
• Preferred audit certification to common industry standards (for example, ASQ, ISO13485, etc.)
• Minimum 3 years of auditing experience
• Minimum 5 years of experience within Pharma/Biopharma, Medical Device, or Biotech industry
• Experience within a cGMP and FDA regulated or other guidance regulated environment
• Experience using MS Office Suite
• Excellent communication and leadership skills as well as a strong work ethic
• Familiarity with ISO 9011:2018 guidelines for auditing management systems