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Grifols · 2 months ago

Quality Compliance Manager

Ohio, United States

Full-time

Onsite

Mid, Senior Level

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909. The Quality Compliance Manager will evaluate processes, develop action plans, and coordinate the strategic implementation of quality system processes and corrective actions at the plasma donor center.

BiotechnologyHealth CareManufacturing

Responsibilities

Maintains oversight of the center’s quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties

Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance

Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties. Maintains and audits training records and files

Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained

Responsible for the personnel functions of the Quality Associate; including direction, assignment of work, hiring, development and training, disciplinary actions, termination, maintenance of personnel records, work schedule and delegation/follow-up of tasks

Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up as required

Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations

Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product

Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness

Oversees product and biohazard waste shipments: Ensures shipments meet regulatory specifications and product release requirements; ensures accurate labeling and documentation; and, authorizes final shipment

Performs a review of the documentation of unsuitable test results and unit lookback information

Performs a review of donor adverse event reports and the applicable related documentation

Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file

Performs employee training observations to ensure staff competency prior to releasing employees to work independently

Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions. Initiates appropriate investigations if these requirements are not met. Initiates rejection of supplies for non-conformance

Determines donor suitability activities and manages donor deferrals as appropriate. Reviews and approves of deferred donor reinstatement activities

Prepares quality analysis reports to track issues and set goals. Does in depth research and analysis to resolve systemic compliance issues

Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented

Holds monthly Quality Meeting to communicate status updates and manage action outcomes

Qualification

Quality Management SystemRegulatory ComplianceRoot-Cause AnalysisTraining Program ManagementAudit OversightCommunication SkillsTeam CollaborationProblem Solving

Required

Bachelor of Science degree or equivalent

Maintains oversight of the center's quality management system and ensures continuous quality improvement, by addressing deficiencies in a timely manner and communicating concerns to the appropriate parties

Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations

Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance

Maintains oversight of center training program by ensuring compliance to program requirements promoting staff competency in their assigned job duties

Maintains and audits training records and files

Collaborates with Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained

Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product

Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness

Performs a review of the documentation of unsuitable test results and unit lookback information

Performs a review of donor adverse event reports and the applicable related documentation

Ensures that job and center annual training (i.e. Advanced cGMP, Blood Borne Pathogen, and others as required) is completed, documented, and on file

Performs employee training observations to ensure staff competency prior to releasing employees to work independently

Ensures that all supplies and materials ordered meet quality requirements prior to use and are always stored in appropriate temperature/facility conditions

Initiates appropriate investigations if these requirements are not met

Initiates rejection of supplies for non-conformance

Determines donor suitability activities and manages donor deferrals as appropriate

Reviews and approves of deferred donor reinstatement activities

Prepares quality analysis reports to track issues and set goals

Does in depth research and analysis to resolve systemic compliance issues

Ensures that Clinical Laboratory Improvement Amendments (CLIA) proficiency test surveys, complaint investigations, and training have been properly documented

Holds monthly Quality Meeting to communicate status updates and manage action outcomes