Quality Specialist

BioSpace; Tampa (FL); On-site; USD 42,000 - 110,000; Full time

Benefits offered by this job

Options for health care benefits

Paid Time Off (PTO)

Company-provided basic life insurance

401(k) Savings Program

Job summary

BioSpace seeks a Quality Specialist to ensure compliance with regulatory standards in the plasma center. The role involves monitoring processes, coordinating training, and leading audits to maintain quality systems. The ideal candidate has a degree in business or biological sciences and experience in a quality position, with strong knowledge of industry regulations.

Qualifications

• 3-5 years’ experience in quality within Plasma or related industry.
• Minimum 1-year supervisory/leadership experience in a regulated environment.

Responsibilities

• Monitors plasma center processes for compliance with SOPs.
• Coordinates training for timely reporting of biologic product deviations.
• Ensures compliance to quality processes and training for operations.

Skills

Strong customer service skills

Knowledge of cGMP

Knowledge of OHSA

Knowledge of FDA regulations

Education

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

Job description

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• 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
  
  
  

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 CSLPlasma

CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging at CSL.

Do work that matters at CSL Plasma!

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