Quality Specialist

CSL; Baltimore (MD); On-site; USD 70,000 - 90,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Quality assurance

SOP compliance

Regulatory knowledge

Leadership

Customer service

Education

Bachelor/Associate degree

Biological sciences degree

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.