Quality GXP Auditor/St. Paul

Quality Remediation Support:
o Develop and maintain Quality Item Prioritization List with Client.
o Evaluate, as directed by Client, open quality items via initial documentation, batch records, forms, SOPs, testing data, personnel interviews, process walk throughs, training program, trending and collaboration with area leaders.
o Drive Quality Remediation item identification, prioritization, and closure through the performance of gap assessments, root cause analysis, risk assessment execution and mitigation activity definition, and preventive action identification and definition.
o Support delivery of quality items including, but not limited to, investigation drafting, preventive action identification and definition, creation and/or revision of quality documentation and or procedures, establishing or revising training material, and change control management.
o Summarize scientific and data driven justification for closure of recommended additional actions regarding Quality items, if necessary and/or requested.
o Execute project deliverables on site based on experience, client requirements and a comprehensive understanding of federal regulatory requirements and ICH (International Council for Harmonization) guidance. ·
o Ensure project deliverables are performed to a high degree of client satisfaction and within the budgeted time.
o Work to ensure the production practices and procedures are in compliance with all applicable internal and external policies procedures, and industry best practices. Develop/optimize new and existing processes to maintain and improve quality/results within Integra.
o Ability to identify and elevate opportunities for improvements based on relevant risk analysis, past manufacturing experience, while ensuring conformance to FDA and international regulations and standards.

B.S./B.A. in scientific discipline as a minimum.
Minimum of 5 years of experience within Pharmaceutical / Biotech / Medical Device industry.
o Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR and ISO 13485.
o Excellent knowledge of Quality system principles; FDA Quality System Regulation (cGMP); 21CFR820, 21CFR809, ISO 13485 Quality system standards for medical device, IS014971 Risk Management Systems required.
o Demonstrated experience with Root Cause Analysis, Change Management, Nonconformance Management, and CAPAs.
o Demonstrated success in earning and maintaining a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.
o Proven record of teamwork, problem solving, project tracking and facilitation of efficient communication between the client and the team.
o Experience creating and working with high performance and high demand teams.
o Quality orientation and high attention to detail.
o Demonstrated ability to work with others and drive results.
Ability to think ahead and prepare sound action plans to achieve results

Quality Remediation Support:
o Develop and maintain Quality Item Prioritization List with Client.
o Evaluate, as directed by Client, open quality items via initial documentation, batch records, forms, SOPs, testing data, personnel interviews, process walk throughs, training program, trending and collaboration with area leaders.
o Drive Quality Remediation item identification, prioritization, and closure through the performance of gap assessments, root cause analysis, risk assessment execution and mitigation activity definition, and preventive action identification and definition.
o Support delivery of quality items including, but not limited to, investigation drafting, preventive action identification and definition, creation and/or revision of quality documentation and or procedures, establishing or revising training material, and change control management.
o Summarize scientific and data driven justification for closure of recommended additional actions regarding Quality items, if necessary and/or requested.
o Execute project deliverables on site based on experience, client requirements and a comprehensive understanding of federal regulatory requirements and ICH (International Council for Harmonization) guidance. ·
o Ensure project deliverables are performed to a high degree of client satisfaction and within the budgeted time.
o Work to ensure the production practices and procedures are in compliance with all applicable internal and external policies procedures, and industry best practices. Develop/optimize new and existing processes to maintain and improve quality/results within Integra.
o Ability to identify and elevate opportunities for improvements based on relevant risk analysis, past manufacturing experience, while ensuring conformance to FDA and international regulations and standards.

B.S./B.A. in scientific discipline as a minimum.
Minimum of 5 years of experience within Pharmaceutical / Biotech / Medical Device industry.
o Considerable hands-on experience in Medical Device manufacturing with strong working knowledge of FDA QSR and ISO 13485.
o Excellent knowledge of Quality system principles; FDA Quality System Regulation (cGMP); 21CFR820, 21CFR809, ISO 13485 Quality system standards for medical device, IS014971 Risk Management Systems required.
o Demonstrated experience with Root Cause Analysis, Change Management, Nonconformance Management, and CAPAs.
o Demonstrated success in earning and maintaining a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.
o Proven record of teamwork, problem solving, project tracking and facilitation of efficient communication between the client and the team.
o Experience creating and working with high performance and high demand teams.
o Quality orientation and high attention to detail.
o Demonstrated ability to work with others and drive results.
Ability to think ahead and prepare sound action plans to achieve results