Associate, Quality Assurance
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.
- 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
APPLY FOR THIS JOB
- 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