Associate, Quality Assurance

Department
Quality Assurance

Location
San Diego

Summary Description
The QA Associate is responsible for supporting the maintenance of the GXP controlled documentation system and for the support necessary to perform production / testing / release activities at PaxVax, San Diego.

Responsibilities:

  • Manage and support document control processes and systems for GxP activities in compliance with internal procedures and policies as well as regulatory requirements.
  • Manage the approval, distribution and archival of new and revised controlled documents.
  • Scans documents for archival, maintains paper and electronic filing system and other related tasks as required.
  • Manages and maintains documents from Contract Manufacturing and Testing Organizations.
  • Ensures controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures.
  • Maintains records management system including secure storage (on and off-site), retrieval, retention and destruction.
  • Develop and deliver training and/or site guidance on document and records management roles, and processes to internal and external customers.
  • Perform Quality metrics
  • Supports internal and external audits as needed.
  • Supports regulatory audits and submissions as needed.
  • Provides recommendations to improve efficiency and compliance

Qualification Requirements:

  • Bachelor’s degree in Sciences or related discipline
  • Minimum of 2-4 years of experience in a GMP related field within a biotechnology / biologics manufacturing facility, with a hands-on role in document management.
  • Proficiency with Microsoft Office applications Word, Excel, Visio, and Adobe Acrobat
  • Attention to detail, clear and effective verbal and written communication skills
  • Excellent project management skills. Ability to multi-task and work well under pressure
  • Highly organized and ability to manage multiple priorities
  • Ability to communicate, relate and work independently with various work groups
  • Excellent documentation skills and attention to detail
  • Demonstrated initiative and accountability in a fast paced environment.
  • Knowledge of Good Manufacturing Practices, Good Documentation practices and regulatory agencies is a plus
  • Some evening/weekend work may be required to support manufacturing on occasion
  • Ability to sit for a long periods of time; majority of work is computer based
  • Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity
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