Quality Manager (HS)
4.
0 Full-time 3 hours ago Full Job Description The OSUCCC-James Cell Therapy Laboratory (CTL) receives, processes, manufactures, stores, distributes and tests cellular therapy products for both routine use and as investigational drugs.
Under the joint direction of OSUCCC-James CTL and Quality and Patient Safety leadership, the CTL Quality Manager utilizes sound Quality Management principles and tools to provide optimal quality of patient care and research services, achieve the highest level of patient safety and outcomes, and support our vision of creating a cancer free world, one person, one discovery at a time.
The CTL Quality Manager manages and performs various quality assurance, quality improvement, and regulatory compliance activities of the CTL.
Strong analytical skills, written and verbal communication, meeting facilitation aptitude and the ability to work independently are required.
30% Quality Management:
Implements, maintains and evaluates the CTL Quality Management Plan Maintains systems and procedures to monitor CTL quality, such as deviation management, corrective and preventive action, environmental monitoring, etc.
Presents at regular Quality Management Team meetings, prepares agendas and minutes of meetings, ensures completion of meeting action items.
Prepares reports for stakeholder and institutional quality oversight groups on a regular or ad hoc basis.
Gathers benchmarking data and best practices from internal and external resources.
Manages the writing and revision of CTL Quality SOPs, forms and other documents.
40% Quality Assurance / Quality Improvement:
Manages CTL deviations, evaluates and recommends corrective actions, performs investigations and risk assessments as needed and communicates relevant information to appropriate stakeholders.
Performs scheduled and unscheduled quality audits, analyzes outcome and process indicators, generates reports, and makes recommendations based on results.
Participates in high level, high impact quality / process improvement initiatives, root cause analyses and corrective and preventive action (CAPA) plans providing analysis and coordination of people and activities, ensuring proper documentation, implementation, and evaluating effectiveness.
Ensures that equipment and the physical plant consistently meet performance requirements through qualification, preventive maintenance, environmental control and monitoring systems, malfunction documentation, etc.
Manages and performs CTL supply and supplier qualification and monitoring processes; reviews and releases incoming supplies for use in cell processing.
Reviews batch records and releases investigational cell products for clinical use to ensure compliance with manufacturing under cGMPs and FDA Investigational New Drug applications (INDs).
Responsible for proper change control and document control of all CTL SOPs.
Prepares, analyses and summarizes equipment and process validation protocols.
20% Regulatory Affairs & Compliance:
Ensures compliance with all regulatory (FDA, ODH) and accreditation (FACT and, as applicable, CAP and CLIA) requirements, coordinates inspections of regulatory and accrediting agencies, prepares response to inspection reports, and ensures timely implementation of corrective measures.
Assists with preparation of regulatory submissions (IND applications, deviation reports, annual reports) Manages process for documentation, investigation and reporting of adverse reactions to cell product infusion, product deviations and complaints, collaborates with Hospital Legal Services to report as needed to FDA and other external parties.
10% Education / Training:
Participates in continuing education, technical procedure training, lectures, audioconferences, grand rounds, and presentations related to cell collection and processing, blood and marrow transplantation and other cell therapies, quality management, regulatory/ billing/ research compliance, current Good Tissue Practices (cGTPs), current Good Manufacturing Practices (cGMPS), and Good Clinical Practices (GCPs).
Represents the OSUCCC-James CTL internally and externally by providing educational seminars and in-service training, presenting achievements at national conferences and preparing publications.
Regular 40 First Shift.
Estimated Salary: $20 to $28 per hour based on qualifications.
0 Full-time 3 hours ago Full Job Description The OSUCCC-James Cell Therapy Laboratory (CTL) receives, processes, manufactures, stores, distributes and tests cellular therapy products for both routine use and as investigational drugs.
Under the joint direction of OSUCCC-James CTL and Quality and Patient Safety leadership, the CTL Quality Manager utilizes sound Quality Management principles and tools to provide optimal quality of patient care and research services, achieve the highest level of patient safety and outcomes, and support our vision of creating a cancer free world, one person, one discovery at a time.
The CTL Quality Manager manages and performs various quality assurance, quality improvement, and regulatory compliance activities of the CTL.
Strong analytical skills, written and verbal communication, meeting facilitation aptitude and the ability to work independently are required.
30% Quality Management:
Implements, maintains and evaluates the CTL Quality Management Plan Maintains systems and procedures to monitor CTL quality, such as deviation management, corrective and preventive action, environmental monitoring, etc.
Presents at regular Quality Management Team meetings, prepares agendas and minutes of meetings, ensures completion of meeting action items.
Prepares reports for stakeholder and institutional quality oversight groups on a regular or ad hoc basis.
Gathers benchmarking data and best practices from internal and external resources.
Manages the writing and revision of CTL Quality SOPs, forms and other documents.
40% Quality Assurance / Quality Improvement:
Manages CTL deviations, evaluates and recommends corrective actions, performs investigations and risk assessments as needed and communicates relevant information to appropriate stakeholders.
Performs scheduled and unscheduled quality audits, analyzes outcome and process indicators, generates reports, and makes recommendations based on results.
Participates in high level, high impact quality / process improvement initiatives, root cause analyses and corrective and preventive action (CAPA) plans providing analysis and coordination of people and activities, ensuring proper documentation, implementation, and evaluating effectiveness.
Ensures that equipment and the physical plant consistently meet performance requirements through qualification, preventive maintenance, environmental control and monitoring systems, malfunction documentation, etc.
Manages and performs CTL supply and supplier qualification and monitoring processes; reviews and releases incoming supplies for use in cell processing.
Reviews batch records and releases investigational cell products for clinical use to ensure compliance with manufacturing under cGMPs and FDA Investigational New Drug applications (INDs).
Responsible for proper change control and document control of all CTL SOPs.
Prepares, analyses and summarizes equipment and process validation protocols.
20% Regulatory Affairs & Compliance:
Ensures compliance with all regulatory (FDA, ODH) and accreditation (FACT and, as applicable, CAP and CLIA) requirements, coordinates inspections of regulatory and accrediting agencies, prepares response to inspection reports, and ensures timely implementation of corrective measures.
Assists with preparation of regulatory submissions (IND applications, deviation reports, annual reports) Manages process for documentation, investigation and reporting of adverse reactions to cell product infusion, product deviations and complaints, collaborates with Hospital Legal Services to report as needed to FDA and other external parties.
10% Education / Training:
Participates in continuing education, technical procedure training, lectures, audioconferences, grand rounds, and presentations related to cell collection and processing, blood and marrow transplantation and other cell therapies, quality management, regulatory/ billing/ research compliance, current Good Tissue Practices (cGTPs), current Good Manufacturing Practices (cGMPS), and Good Clinical Practices (GCPs).
Represents the OSUCCC-James CTL internally and externally by providing educational seminars and in-service training, presenting achievements at national conferences and preparing publications.
Regular 40 First Shift.
Estimated Salary: $20 to $28 per hour based on qualifications.
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