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About the Role
CSL Plasma operates one of the world’s largest and most sophisticated plasma donation networks. The Quality Compliance Specialist ensures compliance with Standard Operating Procedures (SOPs) and applicable regulatory requirements, partnering with management to maintain inspection readiness and facilitate timely reporting of deviations.
Responsibilities
- Monitors plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements.
- Partners with management to ensure the center is always "inspection ready" 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 the Food & Drug Administration (FDA).
- Performs/ensures center records quality review for thoroughness, accuracy, and timeliness of required information.
- Initiates investigations 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 for data integrity, report generation, and data analysis.
- Leads internal audits to monitor facility compliance with SOPs, cGMP, OHSA, FDA, and other applicable regulations.
Requirements
- 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.
Skills
- Customer service
Location
- US
Work Type
- Full-time
Experience Level
- 3-5 years
- 1 year supervisory/leadership
Education Level
- Bachelor's degree
- Associate degree
Salary/Compensations
- $23.04/hour - $25.15/hour
Benefits
- For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.
About the Company
- 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.
- Learn more about CSL Plasma here https://www.cslplasma.com/ and CSL, CSL Behring, CSL Seqirus and CSL Vifor here https://www.csl.com/.
- Learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor here at https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Equal Opportunity
- 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.