CSL · 5 hours ago
Quality Specialist
Augusta, GA
Full-time
Onsite
Entry Level
1+ years expCSL Plasma operates one of the world’s largest and most sophisticated plasma donation networks. The Quality Specialist role provides support in monitoring plasma center processes to ensure compliance with operating procedures and regulatory requirements, while also coordinating training activities and conducting audits.
BiotechnologyHealth CareHealth DiagnosticsMedical
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 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
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
Qualification
Required
High school diploma or equivalent required
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
Preferred
Associate or Bachelor's degree in business administration or biological sciences preferred
Company
CSL
CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$111M2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO
Leadership Team
Jeffrey Ball
Chief Sustainability Officer
Joy Linton
Strategic Advisor
Recent News
Pharma Letter
2026-01-03
2025-10-29
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