Entity: CSL Plasma
Job Category: Quality
Job Family: Plasma Center
Job Type: Full Time
Location: Margate, Florida, United States
Employer Reference: R-282085
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 applicable
Qualifications:
- 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 required
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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CSL Plasma operates one of the world's largest and most sophisticated plasma donation networks, with nearly 330 donation centers in the U.S. and Europe. CSL Plasma is a subsidiary of CSL, a global biopharma company. Plasma collected at CSL Plasma facilities is used by CSL for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 29,000+ people. For more information about CSL Plasma visit, https://www.cslplasma.com/.
For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more visit https://www.csl.com/careers/inclusion-and-belonging
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
