Quality Specialist
CSL · Citrus Heights, CA · 3 days ago
Quality Assurance$26.33–$36.86/hrFull-time
Responsibilities
- Maintains compliance with Standard Operating Procedures (SOPs) and applicable local, state, and federal requirements.
- Partners with management to ensure the plasma center is “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).
- 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.