QA Specialist Iv

1 week ago

Germantown, United States Novavax Full time

If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place.

Individually, we’re skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you

Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world’s most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide.

**Job Summary**

The QA/QC Specialist IV for Quality Operations, is responsible of leading GMP compliance with a focus on oversight of internal manufacturing, QC testing of samples, QA for QC laboratory quality systems and the management of Deviations, Change Controls, and CAPAs. In addition, the QA/QC Specialist IV will support the assessment of Quality Metrics with additional responsibilities for the Quality oversight of records generated during GMP testing and manufacturing of biotechnologically produced products and starting material in a fully functional GMP manufacturing and Quality Control testing facility. The Specialist IV will represent QA/QC Operations on cross-functional teams and support all Novavax Gaithersburg inspection readiness activities.

**Essential Functions**
- Support QA oversight of Operations at Novavax Gaithersburg by assisting in review and approval of GMP documentation related to Quality Control testing raw material sampling and testing, local manufacturing, facility, validation, and materials management activities.
- Assist with review of production batch records generated during the manufacture of product for compliance to current Good Manufacturing Practices (cGMP) and Novavax Standard Operating Procedures (SOPs).
- Makes disposition recommendations to the disposition manager/supervisor based on reviews of executed batch records and supporting data.
- Provide Quality review and approval for Process Descriptions, Master Batch records and Protocols as required.
- Supports Novavax Gaithersburg MD Quality Control testing lab (i.e. Seneca Meadows) through providing QA for QC oversite of testing performance reviews, management/tracking of in-process and finished product samples, issuance of final testing results and assurance of compliance to laboratory quality management systems.
- Assist in the updates and execution of Seneca Meadows SOPs and protocols as needed.
- Assist in the readiness of 700 QO for GMP manufacturing activities by supporting Quality Operations oversight of EMPQ, Facilities, Validation and Operations.
- Review and approval of deviations, CAPAs and Change Controls as it pertains to Novavax Maryland QC and manufacturing operations, disposition of testing, Materials and batch record reviews.
- Support Site Management Review activities with assessment of quality metrics, KPIs and reports associated with Novavax Gaithersburg sites.
- Support inspection readiness activities by participating in the inspection or audit and lead corrective action implementation for identified quality assurance issues.
- Author and/or provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as assigned.
- Actively tracks project timelines and key QA deliverables to ensure compliance expectations are met in a timely manner.
- Leads GMP investigations and collaborates with technical teams and to align compliance expectations and support follow up actions.
- Proactively examines/reviews systems and processes to identify/assess areas for review, improvement, change, or elimination with a focus to simplify and standardize processes. May lead and drive improvements as required.
- Author and/or provide review and approval for new or revised Quality SOPs and other controlled documentation. Author quality documents as assigned.
- Assist management with other non-routine projects as assigned.
- Responsible to ensure appropriate escalation, communication channels are used to ensure management are kept informed of critical issues, as required.
- Support internal and regulatory agency inspections at Novavax Gaithersburg as required.
- Support the preparation of batch disposition documents for review and approval as required.
- Review and approval of manufacturing technology trans

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