| Location | Holly Springs |
Job OverviewReporting to the Front-Line Quality Assurance (FLQA) Senior Manager, the QA Specialist provides strategic and technical support for the Quality Control, FacOps, and Warehouse departments at the Holly Springs site. The role ensures all activities comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual. This is a Monday‑Friday, core business hours position. Candidates must be flexible to support seasonal influenza vaccine production.Key ResponsibilitiesDevelop, review, and manage deviation reports, conduct root cause investigations, and implement CAPAs and effectiveness checks.Prepare and validate change control documents, assess risk, and ensure accurate technical content.Conduct routine QA walkthroughs and process audits across Quality Control, FacOps, and Warehouse.Approve GMP documents such as protocols, test plans, and validation deliverables in collaboration with CQV, MS&T, AS&T, and Engineering.Maintain Quality Management Systems for cGMP areas, including Deviation/CAPA management, Change Management, and document management training systems.Drive compliant use of quality systems and achieve key performance indicators.Assess criticality of deviations and change controls and lead appropriate product quality impact assessments, corrective actions, and batch control activities.Investigate all quality issues, create CAPAs to prevent recurrence, and identify trends or non‑conformances for continuous improvement.Confirm compliance of quality activities in all relevant departments with GxP, Seqirus procedures, and data integrity standards.Develop and implement SOPs and supplemental documents governing each quality system.Review documentation for compliance, completeness, and data integrity, and perform data verification checks for regulatory submissions.Participate in self‑inspections, resolve audit findings, and support site self‑inspections.Ensure on‑time completion of assigned training and serve as a QA partner to support and coach staff on quality mindset and compliance.Act as the primary QA support for Quality Control, FacOps, and Warehouse, facilitating issue triage and escalation.Apply advanced technical knowledge to support risk‑based decision making on key topics or issues.Provide on‑floor coaching to embed a quality culture throughout the site.Advise departments on applicable requirements, deferring to senior QA members for complex issues.Maintain knowledge of Seqirus manufacturing processes, SOPs, policies, and regulatory guidance (GCLP, GMP, QbD).Support inspection readiness through routine walkthroughs, system monitoring, and direct involvement in site self‑inspections.Generate deviation and change control sub‑reports to support Annual Product Quality Review.Educational RequirementsBachelor's degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.).Experience Requirements1–5+ years of GMP experience in pharmaceutical, biotech, or other regulated industry.Strong decision‑making skills.Knowledge of current Good Manufacturing Practices (cGMP) principles.Knowledge of FDA and EMA requirements.Preference for experience in similar analytical processes.Prior laboratory experience (in‑vitro and/or animal studies) in QC, research, development, manufacturing, or quality roles.Equal Opportunity EmployerCSL is an Equal Opportunity Employer. If you have a disability and need a reasonable accommodation during the application process, please visit