Quality Specialist

Responsibilities

• Supports Assistant Manager in monitoring plasma center processes to ensure compliance with Standard Operating Procedures (SOPs) and applicable local, state and federal requirements
• 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 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
• Conducts and may lead internal audits to monitor facility compliance with SOPs, cGMP, OSHA, FDA and other regulations, as applicable
• Collaborates with center management in the development and implementation of continuous improvement plans
  
  

Qualifications

• Bachelor’s/Associate degree in business administration or biological sciences preferred, or equivalent combination of education, training and experience
• 3-5 years' quality or regulatory affairs experience in Plasma or related industry
• Minimum of 1-year leadership experience or equivalent of one-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.

The expected base pay for this position at hiring is $26.33/hour - $28.74/hour. Please note this wage range reflects what CSL expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors.