Plasma Center Quality & Compliance Lead

CSL; Baltimore (MD); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

CSL is seeking a quality-focused professional to oversee plasma center processes and ensure adherence to SOPs, quality systems, and regulatory requirements. The role collaborates with management to keep the center inspection-ready and drives training, records accuracy, and CAPA actions.

Responsibilities include coordinating FDA deviation reporting, maintaining training materials, and leading internal audits to ensure ongoing compliance with cGMP, OSHA, and FDA guidelines.

Qualifikationen

• Bachelor/Associate degree in business administration or biological sciences preferred.
• 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.
• Strong customer service skills.
• Equivalent combination of education and professional work experience required.

Aufgaben

• Monitors plasma center processes to ensure SOPs and local, state, and federal requirements are followed.
• Partners with management to keep the center inspection-ready by aligning with SOPs and the quality system.
• Ensures compliance to quality processes, regulatory requirements, SOPs and necessary training for center operations.
• Coordinates training and facilitates reporting of biologic product deviations to the FDA.
• Performs/ensures center records quality review for thoroughness, accuracy and timeliness of information.
• Initiates investigations to document deficiencies and develop corrective action plans with management.
• Maintains training materials and Learning Management System to ensure data integrity and reporting.
• Leads internal audits to monitor facility compliance with SOPs, cGMP, OSHA, FDA and related regulations.

Kenntnisse

Quality assurance

SOP compliance

Regulatory knowledge

Leadership

Customer service

Ausbildung

Bachelor/Associate degree

Biological sciences degree

Jobbeschreibung

CSL is seeking a quality-focused professional to oversee plasma center processes and ensure adherence to SOPs, quality systems, and regulatory requirements. The role collaborates with management to keep the center inspection-ready and drives training, records accuracy, and CAPA actions.

Responsibilities include coordinating FDA deviation reporting, maintaining training materials, and leading internal audits to ensure ongoing compliance with cGMP, OSHA, and FDA guidelines.