Senior Quality Assurance Specialist
Posted Updated
Job Summary
Are you detail-oriented and passionate about quality and compliance? Join our team as a Sr. Quality Assurance Specialist and help ensure the safety and integrity of life-saving plasma products. In this role, you’ll be a key player in upholding regulatory standards and supporting continuous improvement across the center’s operations. As a Sr. Quality Assurance Specialist, you’ll work closely with the Laboratory Manager to monitor compliance, review documentation, and support training and audit readiness. Your work will support product quality and enhance the current protocols for the laboratory.
What you'll do
- Review manufacturing activities and documentation to ensure compliance with SOPs and regulatory requirements.
- Identify and escalate non-compliance issues that could affect plasma products.
- Investigate deviations and assist in implementing corrective actions.
- Audit records for completeness, consistency, and accuracy to maintain data integrity.
- Monitor equipment qualification, calibration, and maintenance documentation.
- Draft protocols for new and existing instruments and processes within the lab.
- Monitor plasma centers for compliance with customer requirements.
- Ensure proper storage and documentation of supplies, reagents, and equipment.
- Perform quality control checks on stored and shipped products, as well as test reagents.
- Perform reviews of completed runs and changes in supply lots.
- Track and trend quality data to identify improvement opportunities.
- Participate in internal audits and support external inspections.
- Assist in training staff on quality procedures and ensure training records are up to date.
- Promote a culture of continuous improvement and regulatory excellence.
Qualifications and need-to-know
- Bachelor’s degree in life sciences or a related field preferred.
- Minimum two years’ experience in a laboratory setting preferred.
- Ability to analyze data and identify trends.
- Strong organizational and documentation skills.
- Familiarity with FDA, EU GMP, and cGMP standards.
- Excellent communication and collaboration skills.
- Comfortable working in a highly regulated environment with exposure to bloodborne pathogens and cold storage areas.
- Proficiency in Microsoft Office and data entry systems preferred.