Job Description

Medix is seeking a CAPA Investigator for an oral care solution manufacturer located near Schaumburg. The CAPA/NCR Investigator is responsible for identifying, investigating and evaluating nonconformances, noncompliances, unexpected events and determining appropriate corrective and preventive actions. The CAPA/NCR Investigator must demonstrate good technical writing skills, apply risk-based critical thinking and effectively work with quality, regulatory, operations, laboratories, purchasing, engineering, R&D, suppliers and CMO’s to ensure that all events/excursions/issues are appropriately evaluated, investigated, risk and impact assessments are completed, action plans and effectiveness monitoring is defined, executed and closed in a timely and compliant manner.

This position supports compliance remediation activities, Management Review and QMS improvements while applying industry best practices for root cause analysis, data analysis and integrity, and true quality system effectiveness. This position will escalate as needed and ensure the management team is informed of negative trends, metrics/KPIs not meeting targets, and risks to the quality system effectiveness. This position also supports implementation of interim controls and mitigating actions as well as appropriate controls, corrective and sustainable actions, monitoring, metrics, risk-mitigations and documentation is maintained for the CAPA and Management Review programs.

Responsibilities:

• Creating, executing and approving Deviation, Nonconformance and CAPA investigations, evaluations, assessment against regulatory requirements/standards, risk assessments, procedures and change controls.
• Supporting and maintaining the CAPA program (including Deviation and Nonconformance) and Management Review programs and assuring compliance with all applicable global regulatory requirements and standards for the Quality System, all products and processes.
• Provide strategic and risk-based guidance in the execution of CAPA Program and Review Board activities ensuring compliance to procedures, specifications and Quality Agreements for products, processes, roles and responsibilities.
• Creating, monitoring, analyzing data, trends and metrics for the Quality System adequacy and effectiveness which encompass the totality of the Quality Management System’s products, processes, departments, roles and responsibilities.
• Monitoring and coordinating resolution of failures/actions/changes required for issues from Operations, Quality, Regulatory, Purchasing, Suppliers/Vendors, Service Providers, Contract Manufacturing Organizations (CMO), and Distribution.
• Developing and providing training on Root Cause Analysis (RCA), Deviations, Non- conformance and CAPA management, execution, good documentation practices, application of sound scientific logic and compliance justification, impact and risk analysis associated with failures, negative trends and risks to product and process.
• Execute the technical writing and handling of deviations, CAPAs, effectiveness verification and associated changes (new or revised) to minimize impact to production, supply chain, transition, tech transfer or any improvement initiative as well as ensure appropriate handling of any failures/changes with potential impact on product quality, safety, efficacy and impact to the regulatory filing or quality agreement.
• Establish and maintain successful cross-functional relations with Design & Development, Engineering, Manufacturing, Operations, Quality Control, Quality Assurance, Purchasing department and Suppliers/CMOs.
• Maintain governing procedures, forms and records for the CAPA program.
• Serve as a Subject Matter Expert during Internal and External inspections, audits, assessments, and remediation activities.

Requirements:

• 5 years experience in the pharma or medical device regulated industry in Quality Assurance.
• 4 years experience specifically in performing investigations, root cause analysis, risk and impact assessments, CAPA identification and implementation as well as effectiveness
• Experienced in application of, training and creation of cause analysis tools such as 6M, 5Why, Fishbone, Cause & Effect, Is/Is Not etc.
• Strong knowledge of applying data analysis techniques: raw data collection, pareto, statistical techniques, qualitative and quantitative data analysis and metrics, diagnostic analysis, data mining and converting raw data to meaningful metrics and trends to draw conclusions and identify remedial actions.
• Strong leadership skills to motivate and enable cross-functional personnel in meeting objectives, risk-based decision making, timeliness, personal accountability, product/process compliance and safety oriented.
• Strong written and verbal communication skills with effective documentation management skills, technical writing skills and ability to communicate at all levels of the organization to drive timely and effective changes, status reports, resolution of issues, understanding of risks to the Quality System and the business.
• Experienced and practical knowledge of the regulations and standards, (e.g. QSR, ISO13485, Quality System Requirements, CFR 211, 820, Part 11, ICH guidelines, Health Canada and Latin America regulations, FDA guidance documents), affecting Medical Device and Pharma manufacturing sites, Quality System life cycle management, CAPA programs, Change Control, and Data Integrity.
• Proficient use of various software applications such as MS Teams, Word, Excel, Access, PowerPoint, Outlook and web-based applications.