What are the responsibilities and job description for the Quality Specialist position at CSL?
Responsibilities
- Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements
- Partners with management to have the center “inspection ready” at all times by managing compliance to SOPs and the quality system
- Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for plasma center and business operations
- Coordinates training and facilitates processes to support timely reporting of biologic product deviations to Food & Drug Administration (FDA)
- Performs/ensures center records quality review to ensure thoroughness, accuracy and timeliness of required information
- Initiates investigation to ensure documentation of deficiencies and development of corrective action plans, in partnership with management
- Ensures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity, report generation and data analysis
- Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA, and other regulations, as applicableQualifications:
- Bachelor’s/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience
- 3-5 years’ experience in quality within Plasma or related industry
- Minimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environment
- Knowledge of cGMP, OHSA, FDA, and other applicable regulations
- Strong customer service skills
- Equivalent combination of education and professional work experience requiredDifferent qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.