This position is responsible for supporting Assistant Quality Manager in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal international regulatory requirements.
- Assist with the reporting of compliance status to operational and quality management.
- Participate with center management in the development and implementation of continuous improvement plans.
- In the absence of the Assistant Quality Manager (AQM), represent the center during internal and external audits, respond to questions, and may stop operations, including shipments to address quality concerns.
Main Responsibilities and Accountabilities:
- Perform final QA review and release for all shipments and associated documents, to ensure shipment meets customer specifications.
- Conduct daily, weekly, monthly, bi-annual and annual compliance checklist for the systematic monitoring of center quality compliance status. Document findings, develop and implement corrective actions.
- Performs 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.
- Review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.
- 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.
- Assist the AQM with the quality team in identifying and communicating non-conformities to CSL’s POP’s. 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 at the center.
- Assist the AQM with review of Safety, Health and Environment Polices & Procedures. Ensure safety training and safety practices are implemented and followed within the center.
- Assist Regulatory Department in conducting internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OSHA, FDA, and other regulations, as applicable, and develop center response for deficiencies.
- In the absence of the AQM, host external audits conducted by regulatory agencies and customers
- Initiate, investigate and close trackwise reports. Confirm through follow-up, to ensure appropriate corrective action was initiated and implemented.
- Maintain clean efficient work environment, and ensure sufficient operating supplies and forms are available. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedures and documentation audits, as applicable. Promote safety in all actions.
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 an environment free from harassment or intimidation of any employee by co-workers, management personnel or any external source. Immediately report (orally and/or in writing) all incidents of harassment to a manger and HR.
- Maintain professional image and confidentiality of all company records and information at all times.
- May, be cross-trained in all technical areas and other functions to meet business needs.
- Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business.
Qualifications and Experience Requirements:
CSL Plasma is an EEO/AA Employer
- High school diploma or equivalency required
- Associate's or Bachelor’s Degree in business administration or biological sciences preferred
- Minimum 1 year leadership experience required in a regulated health care or medical environment preferred or equivalent work experience
- 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
- Strong written and verbal communication, and interpersonal and presentation skills to drive results
- Working knowledge of Microsoft Office products