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Quality Assurance Specialist IV, Batch Disposition

Employer
Novavax
Location
Gaithersburg, Maryland, United States
Salary
Competitive
Start date
11 Aug 2022
Closing date
10 Sep 2022

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Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

The Quality Assurance Specialist IV, Quality Operations, is responsible for support of GMP compliance with a focus on review of manufacturing records and lot release through provision of critical review, organization, and Quality oversight of records generated during GMP manufacturing of biotechnologically produced vaccines in a fully functional GMP manufacturing facility. The Specialist IV will represent QA Operations on cross-functional teams and contribute to resolution of investigations.

**Must be flexible and open to travel**

Responsibilities include but are not limited to:
  • Review of production batch records generated during the manufacture of vaccines for compliance to current Good Manufacturing Practices (cGMP) and Novavax Standard Operating Procedures (SOPs).
  • Provide Quality review and approval for Process Descriptions, Master and executed batch records.
  • Provide review and approval for generation of new or revised Quality SOPs and other controlled documentation. Author quality documents as assigned.
  • Assist management with other non-routine projects as assigned.
  • Conducts final review and approval of manufacturing-related documentation prior to batch release approval.
  • Represent QA CMO/ CTL management team with cross functional project teams. 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 CMO as required.
  • Preparation of batch disposition documents for review and approval.
  • Review and approval of manufacturing technology transfer, qualification, and validation documents internally and oversight activities to CMOs.
  • Responsible to ensure on time execution of activities and team timeline adherence
  • Proactively identifies and drives remediation of risks within sphere of influence.
  • Management of critical issues and timely resolution, developing solutions to complex problems.
  • Review and Approve Quality events- Change Controls, Deviations, OOS, and CAPAs.
  • Support PIPs to drive thorough and timely batch review and issue management and drive improvements at the CMO
  • Responsible to work with CMO compliance lead to ensure CMO’s/ CTL’s are inspection ready.
  • Responsible to support/ lead any technical transfers / projects/ validation/ launch activities related to.
  • Perform SAP transactions as required
  • Establish tracking system and proactively request batch records and disposition materials based on expected turnaround times and quality agreements.
  • Assist with complex issue resolution.
  • Responsible for the development & assessment of quality metrics, KPIs and reports associated with CMO’s / CTL’s and to recommend actions as a result of such reviews / reports.
  • Facilitate continuous improvement projects
  • Ensure compliance by maintaining training completion on time
  • Other duties as assigned.

Minimum Requirements:
  • BS with minimum 8 years work experience in Quality Assurance and/or Manufacturing; or 6 years and a Masters’ degree; or equivalent relevant experience.
  • GMP or regulated environment experience required
  • 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)

Preferred requirements:
  • 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.

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.

#LI-DC

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Company

Find out more about working for our company

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Brief Company Description; 

We are a biotechnology company committed to help address serious infectious disease globally through the discovery, development, and delivery of innovative vaccines to patients around the world.

Our mission

We never rest in our quest to protect the health of people everywhere.

Novavax is here to make a difference. We’re a biotech company focused solely on developing life-saving vaccines to fight infectious diseases.

What sets us apart? Solid science tested by decades of research. Vaccines developed from trusted technology that are both safe and efficacious.

And a global network that will help ensure our vaccines reach everyone who needs them.

Company info
Website
Mini-site
Novavax
Location
21 Firstfield Rd
Gaithersburg
MD
20878
United States

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