Quality Assurance Officers

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

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. Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. 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.

Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management.

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.

Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. 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.

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.

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

Strong customer service skills

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

See and speak with customers and observe equipment operation