Specialist II/III, QA

About the role

Reporting 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 in all cGMP compliance related matters.

Responsibilities

• Deviation reports which are technically sound and include robust investigation, identification of root cause, development and execution of strong and robust CAPAs and Effectiveness Checks.
• Change controls which are technically accurate and comprehensive in scope including assessment of risk.
• Routine QA walkthroughs and process audits.
• Protocol, test plan and other GMP document QA approvals including validation deliverables in Quality Control, FacOps, and Warehouse collaborating with CQV (Commissioning Qualification and Validation), MS&T (Manufacturing Science and Technology), AS&T (Analytical Science and Technology), and Engineering.
• Ensure compliant use of Quality Systems and achievement of key performance indicators.
• Assess criticality of deviations and change controls.
• Drives appropriate product quality impact assessments, corrective actions, implementation actions, and batch control activities.
• Ensures all minor and major quality issues in their areas are appropriately investigated and CAPAs created to prevent recurrence.
• Drives adherence to and continuous improvement of the quality systems through identification of trends or non-conformances.
• Confirms as applicable that activities in Quality Control, FacOps, Warehouse, CQV (Commissioning Qualification and Validation), MS&T (Manufacturing Science and Technology), AS&T (Analytical Science and Technology), and Engineering are compliant with GxP and/or Seqirus procedural requirements and that data integrity is maintained on an ongoing basis.
• Responsible for the development of Quality Systems in area of oversight.
• Responsible for the development and implementation of standard operating procedures (SOPs) and supplemental documents governing management and usage of each quality system of responsibility.
• Reviews documentation for compliance, completeness and data integrity.
• Performs data verification checks as needed for data obtained from area of oversight being provided to regulatory authorities (e.g., approving data included in source documents, regulatory filings or communications with health authorities).
• Actively participates in self-inspections for Quality Control, FacOps, and Warehouse and drives resolution to audit findings.
• Ensures compliance with Seqirus’ quality, compliance, safety, GMP and regulatory standards at all times.
• Serves as a Quality Assurance partner to Quality Control, FacOps, and Warehouse departments.
• Acts as the primary QA support of Quality Control, FacOps, and Warehouse, including on-the-floor support and the issue triage and escalation process.
• Applies advanced technical and quality knowledge to support risk-based decision making on any key topics or issues.
• Provides on the floor coaching to staff to embed a quality mindset, build compliance and quality knowledge and sustain strong quality culture.
• Advises Quality Control, FacOps, and Warehouse departments on applicable requirements, deferring to more senior members in QA for complex issues.
• Acquires and maintains knowledge of Seqirus manufacturing process, SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that sound advice and appropriate QA technical support on all quality/compliance-related matters are provided to Quality Control, FacOps, and Warehouse departments at the site level for relevant markets.
• Ensures inspection readiness via performing routine quality walkthroughs, monitoring quality system adherence, and direct involvement in Site Self Inspections.
• Generate deviation and change control sub-reports in support of Annual Product Quality Review.

Requirements

• Bachelor’s degree in a relevant scientific discipline (Biology, Microbiology, Chemistry, etc.).
• 1-5+ years' GMP experience in pharmaceutical/biotech or other regulated industry (According to the hiring Level).
• Strong decision-making skills required.
• Knowledge of current Good Manufacturing Practices (cGMP) principles.
• Knowledge of FDA and EMA requirements.
• Knowledge of similar analytical process is preferred.
• Previous work in a laboratory (in vitro and/or animal studies) in a QC, Research, Development, Manufacturing or Quality role required.