Quality Specialist

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.