Quality Specialist (Bilingual)
About The Position
The Quality Specialist provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes and ensuring compliance with CSL Operating Procedures and applicable local, state, and federal requirements. The role supports compliance with training needs, SOPs, processes, and other regulatory and company directives. It reports compliance status data to operational quality management and collaborates with center management on continuous improvement plans. The specialist performs quality assurance reviews and releases shipments, reviews center records, investigates regulatory deficiencies, and determines and documents corrective actions. The role coordinates and monitors center training, maintains personnel training records and the Learning Management System, and supports retraining to address operational or quality issues. It also conducts process assessments and audits, communicates non-conformities, and initiates, investigates, and closes Trackwise reports. The specialist supports internal and external audits, and may represent the center or stop operations, including shipments, to address quality concerns. The role also promotes safety policies and practices, maintains a clean and efficient work environment, protects confidential information, and assists with special projects and other assigned duties. The position requires standing and walking for much of the workday, occasional lifting and carrying, and exposure to varying temperatures, freezers, and odors.
Requirements
- High school diploma or equivalent required.
- Minimum of one year of leadership experience or equivalent experience in a regulated environment.
- Strong customer service skills.
- Strong critical reasoning, decision-making, and problem-solving skills.
- Organizational skills and attention to detail to manage multiple tasks, short deadlines, interruptions, and changing priorities.
- Understanding of Quality Systems and/or regulated training requirements.
Nice To Haves
- Associate or Bachelor's degree in business administration or biological sciences.
Responsibilities
- Perform final QA review and release of shipments and associated documents to confirm they meet customer specifications.
- Review center records for thoroughness, accuracy, and timeliness; investigate deficiencies and document, implement, and assess corrective actions.
- Maintain personnel training documents and the Learning Management System, and coordinate and monitor required training and retraining.
- Conduct process assessments and internal audits, identify and communicate non-conformities, and support center responses to audit findings.
- Initiate, investigate, and close Trackwise reports in a timely manner, verifying that corrective actions are appropriate and effective.
- Promote and monitor compliance with quality, safety, health, and environmental policies and procedures.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
