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@ Novavax
  • Post Date : May 23, 2024
  • Apply Before : Jun 23, 2024
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Job Detail

  • Offered Salary 0
  • Commitment Full Time
  • Compensation Paid
  • Required education level Bachelor’s degree

Job Description

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 transfer, qualification, and validation documents.
  • Proactively identifies and drives remediation of risks within sphere of influence.
  • Management of critical issues and timely resolution, developing solutions to complex problems.
  • Drive and/or facilitate continuous improvement projects.
  • Ensure compliance by maintaining training completion on time.
  • Assist management with other non-routine projects as assigned.
  • Other duties as assigned.

 

Required Knowledge, Skills, and Abilities

  • BS with minimum of 6 + years work experience in Quality Assurance in a GMP or equivalent regulated environment.
  • Excellent understanding of Quality Assurance systems
  • Strong communication and organizational skills
  • Excellent understanding of GMP, GLP, GCP and GCLP expectations
  • Knowledge of global regulatory expectations (including FDA and EMA)
  • The established recognition within QA as a technical expert
  • Demonstrated success in leading investigations and problem resolution
  • Demonstrated success leading a team and training junior staff.
  • Demonstrated interest and ability to manage technical, operational, and administrative aspects of the team
  • Demonstrated ability to apply GMP, GLP, GCP and GCLP expectations
  • The ability to represent the team cross-functionally; to apply an understanding of the team’s place in the larger organization, and discuss changes, progress, and issues as they relate to other areas
  • The flexibility to strategize a new direction of his/her work when change is encountered or necessary; to help teammates with their own agility in a changing context
  • The accountability to have others’ confidence in achieving deliverables that are complex, requiring interaction with other members of the immediate team and beyond
  • The ability to produce high-quality work on complex problems with cross-functional involvement; to anticipate and proactively prevent risks and compromises to quality
  • The capability to recognize inefficiencies in the team and identifies improvements constructively; to work across teams effectively and frequently collaborate on larger items involving other areas. To contribute significantly to cross-functional work; to network with senior internal and external peers in own area of expertise and demonstrates leadership and ownership of issues
  • The capability to consistently develop networks that are diverse in level and function, identify and initiate new relationships as well as creative alliances to accomplish business objectives, and inspire people with diverse needs to work together for mutual benefit.
  • This position may require periodic weekend/evening work.
  • **Must be flexible and open to travel** ​

Education, Experience, Licenses & Certifications

  • BS with minimum of 6 + years work experience in Quality Assurance in a GMP or equivalent regulated environment.
  • Excellent understanding of Quality Assurance systems
  • Strong communication and organizational skills
  • Excellent understanding of GMP, GLP, GCP and GCLP expectations

 

 

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

 

Equal Opportunity Employer/Veterans/Disabled

 

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.

 

Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.

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