FAQs
What are the primary responsibilities of a Quality Specialist at CSL Plasma?
The primary responsibilities include monitoring plasma center processes for compliance with SOPs and regulatory requirements, ensuring the center is "inspection ready," coordinating training, conducting quality reviews of center records, initiating investigations for deficiencies, maintaining training materials, and leading internal audits.
What qualifications are necessary for the Quality Specialist position?
Candidates should preferably have a Bachelor’s or Associate degree in business administration or biological sciences, 3-5 years of quality experience in the plasma or related industry, at least 1 year of supervisory or leadership experience, and knowledge of cGMP, OHSA, and FDA regulations.
Is prior experience in the plasma industry required for this position?
While not strictly required, candidates should have 3-5 years of experience in quality within the plasma or a related industry, making relevant industry experience beneficial for the role.
What skills are important for a Quality Specialist?
Strong customer service skills, attention to detail, good communication abilities, and a comprehensive understanding of regulatory requirements and quality assurance processes are important for a Quality Specialist.
What kind of benefits does CSL Plasma offer for this position?
CSL Plasma offers health care benefits (medical, dental, and vision), prescription drug coverage, life insurance, short- and long-term disability, a 401(k) savings program, Paid Time Off (PTO), and paid observed holidays.
What does "keeping the center ‘inspection ready’" mean?
It means ensuring that all practices, procedures, and documentation comply with regulatory standards and SOPs so that the center can smoothly undergo inspections by regulatory bodies like the FDA at any time.
What is the significance of the Quality Specialist role at CSL Plasma?
The Quality Specialist plays a crucial role in ensuring that the processes at the plasma center are compliant with safety and quality standards, which is vital for the collection of plasma that helps treat patients with rare and serious diseases.
Does this position require supervisory experience?
Yes, a minimum of 1 year of supervisory or leadership experience is preferred or the equivalent of 1 year in a regulated environment is required.
How does CSL Plasma approach diversity and inclusion?
CSL Plasma is committed to reflecting the world around them, and they embrace diversity and inclusion throughout their global organization, which employs individuals in over 35 countries. Feel free to use or modify these questions and answers as needed!