Quality Specialist

CSL Vifor; Springfield (MO); On-site; USD 60,000 - 85,000; Full time

Job summary

CSL Vifor is seeking a Quality Assurance professional in Springfield, MO to monitor plasma center processes and ensure compliance with CSL SOPs, CLIA/COLA, and governing regulations. The role partners with management to drive training, audits, and continuous improvement while safeguarding patient and donor data.

Key duties include final QA release, training management, and coordinating corrective actions, with responsibilities spanning internal and external audits and adherence to HSE/OSHA

Qualifications

• Minimum 1-year leadership experience or equivalent in a regulated environment.
• Strong customer service skills.
• Strong critical reasoning, decision-making and problem solving.
• Organizational skills and attention to details to handle multiple tasks and deadlines.
• Understand Quality Systems and/or regulated training requirements.

Responsibilities

• Perform final QA review and release for all shipment and related documents to meet customer specifications.
• Ensure center records QA review for thoroughness, accuracy and timeliness; initiate investigations and corrective actions as needed.
• Maintain and review Plasma center training documents for CSL procedures and regulatory requirements.
• Maintain Learning Management System data integrity, reporting and data analysis.
• Schedule, coordinate and monitor delivery of all training (new hire, annual, retraining).
• Collaborate with center management to deliver retraining for quality improvements.
• Conduct periodic process assessments to ensure compliance and corrective actions with management.
• Identify non-conformities to CSL SOPs and participate in quality team activities and audits.
• Promote Safety, Health and Environment policies and ensure training practices are followed.
• Lead internal audits and respond to deficiencies; host external audits when needed.
• Initiate, investigate and close Trackwise reports; ensure corrective actions are effective.

Skills

Leadership

Customer Service

Regulated Environment

Attention to Detail

Quality Systems

Education

High school diploma

Associate/Bachelor's in business administration or biological sciences

Job description

The Opportunity

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.

• 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 be able to represent the center during internal and external audits, responds 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.

You will report to the Assistant Manager Quality

The Role

• 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.
• Perform 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, SOP’s, 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.
• Initiates 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
• Collaborates 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.
• Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting 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.
• Conducts 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 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 hyperimmune 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.dd 4-6 key responsibilities of the job

Your skills and experience

Education

High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred.

Experience

• 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

(physical & mental requirements)

• 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