Quality Specialist

CSL Vifor; Philadelphia (Philadelphia County); On-site; USD 70,000 - 110,000; Full time

Job summary

CSL Vifor in the Philadelphia area is seeking a quality professional to monitor plasma center processes and ensure strict adherence to SOPs and all applicable local, state and federal requirements. This role supports the center by maintaining inspection readiness through proactive management of the quality system and ongoing training records, with an emphasis on accurate documentation and timely reporting.

Responsibilities include coordinating training, maintaining the Learning Management

Qualifications

• 3–5 years’ experience in quality within Plasma or related industry.
• Minimum 1-year supervisory/leadership experience or equivalent in a regulated environment.
• Knowledge of cGMP, OSHA, FDA, and other applicable regulations.

Responsibilities

• Monitors plasma center processes to ensure SOP compliance and regulatory requirements.
• Partners with management to keep the center inspection-ready and compliant with the quality system.
• Leads internal audits to monitor facility compliance with cGMP, OSHA, FDA and other regulations.

Skills

Quality Assurance

Regulatory knowledge

Customer service

Documentation

Education

Bachelors/Associates in business or sciences

Job description

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.