Job: Quality Assurance Senior Specialist - Audits, Medicago USA, Durham, NC
Under the supervision of the Quality Compliance Supervisor, the candidate is primarily responsible for the execution of the internal audit program and to support quality risk management. Responsibilities include acting as a lead auditor to assess site GMP operations against regulatory expectations and Internal Medicago guidelines and procedures as well as provide support for other Quality Systems such as CAPAs, Inspection Management and Annual Product Reviews (APRs).
• Manage all aspects of the audit lifecycle: to include scheduling, planning, issuing agendas, executing, issuing reports, reviewing and approving reports, evaluating responses, requesting clarification, issuing CAPA and closing out of audits.
• Incorporate sound risk management principles for the establishment of the annual audit schedule.
• Schedule, plan and prepare for internal audits collaborating with auditee.
• Identify compliance risks and escalate issues to appropriate levels of management for resolution
• Create, publish and maintain metrics that measure the status and effectiveness of the audit program.
• Promote awareness across the commercial manufacturing platform of current regulatory agency requirements and trends.
• Assist in development of effective auditing and risk management tools and training aids.
• Identify and drive program audit and risk management improvements.
• Ensure CAPAs initiated for audit findings and risk management are appropriate and adequately address to compliance issue.
• Support inspection management and APR activities.
• Serve as a back-up resource for other Quality System activities as assigned.
• Pharmaceutical manufacturing, packaging, or laboratory experience including at least 10 years in GMP QA/QC/Compliance.
• Working knowledge of 21 CFR Part 11, 210, 211, 600 and/or ICH guidelines in a Quality Organization.
• Audit Certification preferred by not required.
• Strong knowledge of Internal Audit and Risk Management Programs with expertise in scientific technical writing and reviewing of documentation and GMP operations from a compliance perspective.
• Demonstrated expertise with the application of quality assurance systems & regulatory subject matter for audits, inspection management, APRs and quality risk management.
• Demonstrated ability to analyze and communicate audit program status and issues in Senior Management forums.
• Must be an organized results oriented self-starter with attention to detail and have the ability to independently and efficiently multitask in a fast paced environment with excellent communication skills (both written and oral).
• Experience with MS Office & enterprise applications (example: MasterControl, LIMS, ERP, etc.) preferred.
• While performing the duties of this job, the employee is regularly required to sit and use hands to type or handle various items. The employee is occasionally required to stand, walk, reach or stoop. The employee must occasionally lift and/or move up to 20 pounds.