Quality Specialist

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

Job summary

CSL is seeking a Quality Assurance professional to monitor plasma center processes and ensure compliance with SOPs and regulatory requirements. You will work with management to keep the center inspection-ready and uphold the quality system.

Requirements include 3–5 years in quality within plasma or related industries and 1+ year of supervisory experience. A Bachelor’s/Associate degree in business administration or biological sciences, or an equivalent combination, is preferred.

Qualifications

• Experience in quality within plasma or related industry (3–5 years).
• Knowledge of cGMP, OSHA, FDA regulations.
• Supervisory/leadership experience (minimum 1 year).
• Bachelor’s or Associate degree in business/biology or equivalent.

Responsibilities

• Monitors plasma center processes to ensure SOPs and regulatory requirements are met.
• Partners with management to keep the center inspection-ready at all times.
• Ensures compliance to quality processes, regulatory requirements, SOPs and training.
• Coordinates training and facilitates reporting of biologic product deviations to FDA.
• Performs/ensures center records quality review for thoroughness and timeliness.
• Initiates investigations to document deficiencies and corrective action plans.
• Maintains training materials and Learning Management System data integrity.
• Leads internal audits to monitor facility compliance with SOPs, cGMP, OSHA, FDA.

Skills

SOP compliance

Regulatory knowledge

Quality systems

Training management

Education

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

Job description

• 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
• 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.