Associate, Quality Assurance - San Diego, CA | Biospace
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Associate, Quality Assurance

PaxVax, Inc.

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Location:
San Diego, CA
Posted Date:
8/15/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biotechnology, QA, Quality, Quality Assurance,

Job 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

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