Quality Specialist
CSL, Auburn, AL, United States
Overview
This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.
You will report to the Assistant Manager Quality.
Responsibilities
Reporting compliance status data to operational quality management
Collaborate with center management in the development and implementation of continuous improvement plans
Collaborate with Assistant Manager of Quality (AMQ), to represent the center during internal and external audits, respond to questions, and may stop operations, including shipments to address quality concerns
Responsible for coordinating and managing training activities, policies and processes at the center level
Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications
Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action
Maintain and review plasma center personnel training documents to ensure documents comply with CSL procedures, SOPs, CLIA/COLA and other applicable requirements
Maintain the learning management system to ensure data integrity, report generation and data analysis to comply with company and regulatory standards
Initiate schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used
Collaborate with center management when viewing the quality management system to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues
Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management
Identify and communicate non‑conformities to CSL’s SOPs. In the absence of the AQM, may conduct monthly quality team meetings to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation
Promote safety, health and environment policies & procedure. Ensure safety training and safety practices are implemented and followed within the center
Conduct and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers
Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow‑up, to ensure appropriate corrective action was initiated, implemented, and effective
Maintain a clean, efficient work environment. Comply with all health safety and environmental (HSE) and occupational safety and health administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable
Follow all standard operating procedures (SOPs), company policies and procedures
Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, civil rights, EEOC, FDA, GHA, HIPAA, and OSHA
Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper‑immune programs at the center, if applicable
Assist plasma center staff in completing other special projects or assignments, as requested
Perform other job‑related duties, as assigned
Qualifications
High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred
Minimum 1‑year leadership experience or equivalent of one‑year experience in a regulated environment
Strong customer service skills
Strong critical reasoning, decision‑making and problem‑solving skills to analyze situations
Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
Understand quality systems and/or regulated training requirements
Working Conditions
Occasionally required to work with the public when they are dissatisfied
80% of the time standing and walking and 20% of the time sitting
Reach, bend, kneel and have high level of manual dexterity
See and speak with customers and observe equipment operation
Occasionally be required to lift and carry 25 lbs
Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit our accessibility statement.
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This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.
You will report to the Assistant Manager Quality.
Responsibilities
Reporting compliance status data to operational quality management
Collaborate with center management in the development and implementation of continuous improvement plans
Collaborate with Assistant Manager of Quality (AMQ), to represent the center during internal and external audits, respond to questions, and may stop operations, including shipments to address quality concerns
Responsible for coordinating and managing training activities, policies and processes at the center level
Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications
Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action
Maintain and review plasma center personnel training documents to ensure documents comply with CSL procedures, SOPs, CLIA/COLA and other applicable requirements
Maintain the learning management system to ensure data integrity, report generation and data analysis to comply with company and regulatory standards
Initiate schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used
Collaborate with center management when viewing the quality management system to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues
Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management
Identify and communicate non‑conformities to CSL’s SOPs. In the absence of the AQM, may conduct monthly quality team meetings to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation
Promote safety, health and environment policies & procedure. Ensure safety training and safety practices are implemented and followed within the center
Conduct and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers
Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow‑up, to ensure appropriate corrective action was initiated, implemented, and effective
Maintain a clean, efficient work environment. Comply with all health safety and environmental (HSE) and occupational safety and health administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable
Follow all standard operating procedures (SOPs), company policies and procedures
Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, civil rights, EEOC, FDA, GHA, HIPAA, and OSHA
Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper‑immune programs at the center, if applicable
Assist plasma center staff in completing other special projects or assignments, as requested
Perform other job‑related duties, as assigned
Qualifications
High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred
Minimum 1‑year leadership experience or equivalent of one‑year experience in a regulated environment
Strong customer service skills
Strong critical reasoning, decision‑making and problem‑solving skills to analyze situations
Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
Understand quality systems and/or regulated training requirements
Working Conditions
Occasionally required to work with the public when they are dissatisfied
80% of the time standing and walking and 20% of the time sitting
Reach, bend, kneel and have high level of manual dexterity
See and speak with customers and observe equipment operation
Occasionally be required to lift and carry 25 lbs
Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit our accessibility statement.
#J-18808-Ljbffr