Quality Specialist

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 operates one of the world’s largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL 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 company, CSL, headquartered in Melbourne, Australia, employs 32,000 people.

We Want Csl To Reflect The World Around Us

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. Learn more Inclusion and Belonging | CSL.

Do Work That Matters At Csl Plasma!