QA Compliance Auditor (CMF)
Position Summary:
This individual is responsible for managing the internal audit program and running inspection readiness workstreams for the KBI Commercial Manufacturing Facility (CMF) in Durham, North Carolina. This individual manages all QA activities related to internal audits of the KBI CMF site. They are responsible for planning, executing, and reporting on site audits of internal CMF processes, systems, and facilities to ensure compliance with current Good Manufacturing Practices (cGMP), relevant regulations and company quality standards. This role is critical in identifying and mitigating risks to product quality, safety, and efficacy for projects being executed in a contract manufacturing organization (CMO) setting.
Position Responsibilities:
- Provide support into the KBI Compliance Programs supporting commercial operations at the site level.
- Planning, scheduling, conducting, and closing internal CMF site audit activities of all KBI departments involved in GMP activities.
- Evaluating audit findings and assessing the efficiency of operations and compliance with relevant corporate policies and regulations through the execution of audit work programs.
- Preparing and distributing reports to operations staff, management, and senior leadership to communicate audit findings and recommendations, ensuring all significant areas are appropriately documented and addressed.
- Maintaining knowledge and understanding of audit findings and audit standards, regulatory issues, and industry updates.
- Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
- Driving a culture of compliance at KBI through audits, implementation of site specific procedures, workshops and training.
- Reviewing and approving investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans related to audit observations.
- Hosting site audits/inspections, ensuring proper conduct of customer-initiated audits and mock regulatory inspections, and assisting in regulatory facility inspections.
- Managing audit projects and activities of varying complexity to support KBI CMF compliance activities, including key departmental process improvement initiatives, educational compliance seminars, special projects and ad-hoc activities as requested by KBI CMF management.
Minimum Requirements:
- BS in scientific or technical discipline (e.g., pharmacy, chemistry, biology, engineering) and a minimum of ten (10) years’ experience or MS and eight (8) years’ experience in a QA cGMP regulated environment within pharmaceutical or biopharmaceutical industry required.
- Minimum of 5 years of experience in quality assurance auditing roles within the pharmaceutical industry, with a preference for focus on contract manufacturing.
- Strong understanding of life sciences industry risks and regulatory requirements defined by applicable regulations as well as a demonstrated ability to apply industry guidance and standards in delivery of work product.
- Proven track record of conducting successful audits and driving quality improvements.
- Strong knowledge of cGMP regulations and other relevant standards is required.
- Experience in audit and inspection programs within regulated operations.
- Solid experience managing and executing Quality Systems.
- Additional experience in Manufacturing, Quality Control or Technical Operations within the biotechnology industry is required. ASQ Certified Quality Auditor (CQA) or equivalent certification preferred.
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