Quality Specialist
Responsibilities:
o Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirementso Partners with management to have the center inspection ready at all times by managing compliance to SOPs and the quality systemo Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for plasma center and business operationso Coordinates training and facilitates processes to support timely reporting of biologic product deviations to Food & Drug Administration (FDA)o Performs/ensures center records quality review to ensure thoroughness, accuracy and timeliness of required informationo Initiates investigation to ensure documentation of deficiencies and development of corrective action plans, in partnership with managemento Ensures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity, report generation and data analysiso Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA, and other regulations, as applicable
Qualifications:
o Bachelor's/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experienceo 3-5 years' experience in quality within Plasma or related industryo Minimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environmento Knowledge of cGMP, OHSA, FDA, and other applicable regulationso Strong customer service skillso 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.Our BenefitsCSL offers the following benefits for this full-time position:
Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL's 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https:
//cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35
countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma! Recommended Skills Auditing Biology Business Administration Corrective And Preventive Action (Capa) Customer Service Data Analysis Apply to this job. Think you're the perfect candidate? Apply on company site $(document).ready( function() $(#ads-desktop-placeholder).html(
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n Estimated Salary: $20 to $28 per hour based on qualifications.
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