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Quality Specialist

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CSL

1mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Tampa
  • Quick Apply

AI generated summary

  • 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.

Requirements

  • 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.

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

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!

CSL

Science & Healthcare
Industry
10,001+
Employees
1916
Founded Year

Mission & Purpose

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.