Large

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.

Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

Science & Healthcare

Science

You should have strong attention to detail, analytical skills, knowledge of quality standards, ability to work collaboratively, and experience in quality assurance or related fields.

You will ensure product quality by conducting inspections, monitoring compliance, analyzing data, and collaborating with teams to implement quality improvement initiatives.

Tampa

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.

Our Benefits

CSL 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 Plasma

CSL 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 us

As 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!

Quality Specialist - CSL

&lt;strong&gt;Responsibilities&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt; Under general direction, monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements&lt;/li&gt;&lt;li&gt; Partners with management to have the center “inspection ready” at all times by managing compliance to SOPs and the quality system&lt;/li&gt;&lt;li&gt; Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for plasma center and business operations&lt;/li&gt;&lt;li&gt; Coordinates training and facilitates processes to support timely reporting of biologic product deviations to Food &amp;amp; Drug Administration (FDA)&lt;/li&gt;&lt;li&gt; Performs/ensures center records quality review to ensure thoroughness, accuracy and timeliness of required information&lt;/li&gt;&lt;li&gt; Initiates investigation to ensure documentation of deficiencies and development of corrective action plans, in partnership with management&lt;/li&gt;&lt;li&gt; Ensures training materials/documents are maintained and modified regularly; maintains the Learning Management System to ensure data integrity, report generation and data analysis&lt;/li&gt;&lt;li&gt; Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA, and other regulations, as applicable&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;&lt;strong&gt;Qualifications&lt;br&gt;&lt;br&gt;&lt;/strong&gt;&lt;ul&gt;&lt;li&gt; Bachelor’s/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience&lt;/li&gt;&lt;li&gt; 3-5 years’ experience in quality within Plasma or related industry&lt;/li&gt;&lt;li&gt; Minimum 1-year supervisory/leadership experience or equivalent of 1-year experience in a regulated environment&lt;/li&gt;&lt;li&gt; Knowledge of cGMP, OHSA, FDA, and other applicable regulations&lt;/li&gt;&lt;li&gt; Strong customer service skills&lt;/li&gt;&lt;li&gt; Equivalent combination of education and professional work experience required&lt;br&gt;&lt;br&gt;&lt;/li&gt;&lt;/ul&gt;Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.&lt;br&gt;&lt;br&gt;&lt;strong&gt;Our Benefits&lt;br&gt;&lt;br&gt;&lt;/strong&gt;CSL 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.&lt;br&gt;&lt;br&gt;&lt;strong&gt;About CSL Plasma&lt;br&gt;&lt;br&gt;&lt;/strong&gt;CSL 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.&lt;br&gt;&lt;br&gt;&lt;strong&gt;We want CSL to reflect the world around us&lt;br&gt;&lt;br&gt;&lt;/strong&gt;As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity &amp;amp; Inclusion at CSL.&lt;br&gt;&lt;br&gt;&lt;strong&gt;Do work that matters at CSL Plasma!&lt;/strong&gt;

CSL

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