Quality Specialist - Plasma Center

CSL; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

A global biopharma company is seeking a Quality Assurance Supervisor at its plasma donation center in Indianapolis. This role involves ensuring compliance with quality processes and applicable regulations, as well as leading training and internal audits. The ideal candidate will have 3-5 years of experience in quality within the plasma industry and at least one year of supervisory experience. Join a mission-driven team at CSL Plasma, where your work will contribute to lifesaving therapies globally.

Qualifications

• 3-5 years’ experience in quality within Plasma or related industry.
• Minimum 1-year supervisory/leadership experience or equivalent in a regulated environment.
• Equivalent combination of education and professional work experience required.

Responsibilities

• Monitor plasma center processes to ensure compliance with SOPs.
• Ensure timely reporting of biologic product deviations to FDA.
• Lead internal audits to monitor facility compliance with regulations.

Skills

Quality compliance

Training coordination

Supervisory experience

Knowledge of cGMP

Biological sciences understanding

Education

Bachelor’s/Associate degree in business administration or biological sciences

Job description

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
• 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.

About CSL Plasma

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.

You Belong at CSL

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

Equal Opportunity Employer

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.