Quality Assurance Lead – Plasma Center Compliance

CSL; Newark (DE); On-site; USD 55,000 - 75,000; Full time

Job summary

CSL Plasma is seeking a Center Quality role to assist the Assistant Manager of Quality in monitoring center processes to ensure compliance with CSL SOPs and applicable regulations. You will help manage training, records, audits, and continuous improvement initiatives at the plasma center.

The position reports to the Assistant Manager of Quality and requires familiarity with cGMP, CLIA/COLA, FDA, OSHA, and related training requirements.

Qualifications

• Minimum 1-year leadership experience or equivalent in a regulated environment.
• Strong customer service skills.
• Strong critical reasoning, decision-making and problem solving skills.
• 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 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.
• 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 SOPs. 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.

Skills

Leadership experience

Customer service

Critical thinking

Problem solving

Organizational skills

Quality systems understanding

Education

Associate or Bachelor’s degree in business administration or biological sciences

Job description

CSL Plasma is seeking a Center Quality role to assist the Assistant Manager of Quality in monitoring center processes to ensure compliance with CSL SOPs and applicable regulations. You will help manage training, records, audits, and continuous improvement initiatives at the plasma center.

The position reports to the Assistant Manager of Quality and requires familiarity with cGMP, CLIA/COLA, FDA, OSHA, and related training requirements.