Quality Specialist at CSL Plasma

Responsibilities:Under general direction monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local state and federal requirementsPartners with management to have the center inspection ready at all times by managing compliance to SOPs and the quality systemEnsures compliance to quality processes regulatory requirements SOPs and necessary training for plasma center and business operationsCoordinates 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 informationInitiates investigation to ensure documentation of deficiencies and development of corrective action plans in partnership with managementEnsures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity report generation and data analysisLeads internal audits to monitor facility compliance with SOPs cGMP OHSA FDA and other regulations as applicableQualifications:Must be able to work a flexible schedule including every other SaturdayBachelors/Associate degree in business administration or biological sciences preferred or equivalent combination of education training and experience3-5 years experience in quality within Plasma or related industryMinimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environmentKnowledge of cGMP OHSA FDA and other applicable regulationsStrong customer service skillsEquivalent 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.About CSLPlasmaCSL Plasma operates one of the worlds largest and most sophisticated plasma collection networkswith over 350 plasma collection centers in the U.S. Europe and China. Headquartered in Boca Raton Florida CSL Plasma is a subsidiary ofCSL Behring a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent companyCSLheadquartered in Melbourne Australia employs 32000 people.Learn more about CSL Plasma here and CSL CSL Behring CSL Seqirus and CSL Vifor here more about CSL CSL Behring CSL Seqirus and CSL Vifor here at and CSL Plasma at BenefitsFor more information on CSL Plasma benefits visit Belong at CSLAt 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 Opportunity EmployerCSL 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 Experience:IC Key Skills Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP Employment Type : Full-Time Experience: years Vacancy: 1