Job: Quality Assurance Senior Specialist - Inspection Management, Medicago USA, Durham, NC
Under the supervision of the Quality Compliance Supervisor, the candidate is primarily responsible for the execution of the Inspection and Risk Management programs and Annual Product Reviews (APRs). Responsibilities include acting as a lead in preparing the site for PAI and routine regulatory inspections, Risk Management subject matter expert; as well as, provide support for other Quality Systems such as Change Controls, site quality metrics, internal audits, etc.
• Independently lead/participate in global regulatory inspections.
• Provide support in the overall execution of the regulatory inspection management strategy including site preparation through focused area site readiness audits.
• Provide oversight and coordination of commitments following regulatory inspections, maintain up to date records and evidence to support appropriate closure on audit internal and external audit findings.
• Support the site in devising and executing remediation actions to ensure compliance to regulatory expectations
• Promote awareness across the commercial manufacturing platform of current regulatory agency requirements and trends.
• Partner cross-functionally to train the inspection management team.
• Assist in development of effective inspection and risk management tools and training aids.
• Identify and drive risk assessment program improvements.
• Perform regular analysis of regulatory observations, prepare and coordinate follow-up/gap analysis to prevent re-occurrence
• Provide expertise to the organization on new and developing GMP regulatory requirements and trends to help ensure the company remains up-to-date with current GMP
• Develop process for gathering information to write impactful APRs.
• Write/revise SOPs that govern assigned processes.
• 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.
• Strong knowledge of Regulatory Inspection 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 for inspection management, risk management and APRs.
• 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.