Quality Specialist
CSL · Margate, FL · 1 mo ago
On-siteQuality AssuranceFull-time
Responsibilities
- Maintains compliance with Standard Operating Procedures (SOPs) and regulatory requirements
- Manages compliance to SOPs and the quality system to ensure the center is “inspection ready”
- Ensures compliance to quality processes, regulatory requirements, SOPs, and necessary training
- Coordinates and facilitates processes for timely reporting of biologic product deviations to the FDA
- Reviews center records for thoroughness, accuracy, and timeliness
- Initiates investigations and develops corrective action plans to address deficiencies
- Maintains and updates training materials and documents in the Learning Management System
- Leads internal audits to monitor compliance with SOPs, cGMP, OHSA, FDA, and other applicable regulations
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