Novavax
  • 25-Aug-2017 to 24-Oct-2017 (EST)
  • Quality Assurance
  • Gaithersburg, MD, USA
  • Full Time - Exempt

At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today!  We seek to attract, develop and retain talented people who share our passion for science, medicine, and human health.  We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees.  We are a fast paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.  

Overview: 

We are seeking a QA Compliance Specialist IV to join our Quality Assurance Department. The qualified individual should have experience with US and international GMP regulations, guidance documents, and industry best practices in multiple areas of a GMP environment.   The role provides quality oversight of validation activities within the following areas: facility, utility, computer/equipment, process validation, and cleaning validation.

Responsibilities include but are not limited to: 

  • Applying a risk based approach to qualification/validation program.
  • Provides the QA review and approval of qualification protocols and reports.
  • Investigation of discrepancies during the execution of protocols as well as other atypical events, deviations, and non-conformances as required.
  • Interacts directly with internal and external stakeholders on a routine basis.
  • Guides internal stakeholders to develop appropriate responses to audit observations and assures CAPA appropriateness.
  • Provides compliance and regulatory inspection support and training for the sites.
  • Reviews, tracks and/or trends routine quality data. Reports adverse trends to management with remediation plan.
  • Authors, reviews, and approves controlled documents (i.e., SOPs, Specifications, Methods, Protocols), as necessary.
  • Maintains routine programs and processes in compliance with Novavax SOPs and relevant GxP regulations.
  • Stays current with changes to current Good Manufacturing Practices, including FDA, EU, and other regulatory bodies (relevant to NVAX activities) and guidance bodies including ICH, ISPE, etc. so that NVAX's compliance policies are current and effective.
  • Other duties as assigned by management.

 Minimum Requirements:

  • BS in technical discipline (Engineering, Chemistry, Microbiology, Biology).
  • 5+ years applicable experience in a quality support function specific to qualifications encompassing computer systems validation and at least two of the following areas: Equipment Qualification, Utility Qualification, Process Validation, or Cleaning Validation.
  • 6+ years' experience in GMP pharmaceuticals, biologics and/or vaccine manufacturing.
  • Knowledgeable in principles and current Good Manufacturing Practices (GMPs) in a development to commercial application setting.
  • Strong knowledge foundation of FDA regulations regarding the manufacture and support of biologics (11, 210, 211, and 610 CFR).Experience in various validation topics which include Process, Cleaning, Equipment, Utilities, and IT systems.
  • Experience in applying risk-based approach to Equipment/Utility/Computer Systems Qualification.
  • Experience with and knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control.
  • Excellent multi-tasking, analytical, organizational and teamwork skills.
  • Ability to troubleshoot, identify root cause and systematically resolve problems.
  • Ability to communicate clearly and effectively with all levels of the organization.
  • Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.

 Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Our product pipeline targets a variety of infectious diseases with vaccine candidates currently in clinical development for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and Ebola virus (EBOV). Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden and employs over 300 individuals dedicated to developing novel vaccines to address infectious disease. 

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

We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.

Novavax
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