Overview
Quality Assurance Specialist Jobs in Raleigh-Durham-Chapel Hill Area at SDI International
Title: Quality Assurance Specialist
Company: SDI International
Location: Raleigh-Durham-Chapel Hill Area
The Quality Assurance Specialist supports the Quality Assurance Manager in maintaining and improving Quality Systems, ensuring compliance with applicable regulations, company policies, and quality standards. This role provides guidance to facility personnel on quality processes, supports manufacturing operations, oversees documentation control activities, conducts quality reviews, investigates deviations, and helps drive continuous improvement initiatives.
Key Responsibilities
Quality Systems Support
- Support the implementation, maintenance, and continuous improvement of Quality Systems.
- Provide guidance and direction to facility personnel regarding quality procedures, compliance requirements, and system expectations.
- Assist in maintaining electronic Quality Management Systems (eQMS).
- Track Quality System effectiveness through audits, metrics, and key performance indicators (KPIs).
- Assist in training QA/QC team members on Quality Systems and procedures.
Document Control
- Manage and maintain controlled documentation, ensuring documents are reviewed, revised, approved, issued, and archived in accordance with established procedures.
- Serve as a technical writer for policies, Standard Operating Procedures (SOPs), forms, worksheets, job aids, and other quality-related documentation.
- Partner with manufacturing teams to identify documentation needs and support document development efforts.
Batch Record Management
- Assist in the creation, issuance, and maintenance of batch records and manufacturing forms.
- Perform initial reviews of completed batch records to ensure accuracy, completeness, and compliance.
- Identify documentation corrections and work with appropriate personnel to resolve discrepancies.
Validation and Compliance
- Support validation activities by reviewing executed validation protocols and ensuring work is completed according to approved plans.
- Provide oversight and guidance to personnel performing validation activities.
- Ensure compliance with applicable quality standards and regulatory requirements.
Deviation Investigations and CAPA
- Initiate, document, and investigate deviations associated with manufacturing and product release activities.
- Analyze Quality System data to identify trends, recurring issues, and opportunities for improvement.
- Recommend and support the implementation of Corrective and Preventive Actions (CAPA).
Material Release and Manufacturing Support
- Support material release activities, including inspection and verification of incoming materials against established specifications.
- Serve as a quality liaison for manufacturing projects and operational initiatives.
- Collaborate with cross-functional teams to ensure quality requirements are met throughout manufacturing processes.
Metrics and Reporting
- Track, trend, and report manufacturing errors, deviations, and quality metrics.
- Support the development and monitoring of KPIs to measure quality performance and process effectiveness.
Qualifications
- Experience in Quality Assurance, Quality Systems, Manufacturing, or a related regulated environment.
- Knowledge of Good Manufacturing Practices (GMP), quality documentation, deviation management, CAPA, and validation processes.
- Strong technical writing and documentation skills.
- Excellent analytical, organizational, and problem-solving abilities.
- Ability to work effectively across multiple departments and support cross-functional initiatives.
- Experience with electronic Quality Management Systems (eQMS) preferred.
- Experience with MasterControl is highly desirable.
Additional Requirements
- Maintain annual competencies in required quality functions.
- Complete all required Environmental Health & Safety (EHS) training modules.
- Participate in a minimum of five (5) hours of continuing education annually related to quality systems, cellular therapy, or relevant industry topics.
- Perform additional duties and responsibilities as assigned by the QA Manager and/or Directors.
