Biotech and Pharmaceutical, Cross-Functional, Current Good Manufacturing Practice (cGMP), Document Control, Document Management, Documentation, Maintain Compliance, Quality Assurance, Quality Control, Quality Management, Systems Administration/Management, Team Player, Technical Writing, Visual Studio Application Lifecycle Management (ALM) (fka Visual Studio Team System / VSTS ), Writing Skills
Location: Portsmouth, NH
Duration: 06 Months
M-F 5x onsite 1st shift (8am - 5pm)
Job Description:
We are seeking a highly motivated and experienced Quality Systems Support Specialist to join our team in Vacaville, CA. In this role, you will provide essential support to the Quality System Management process with document control and PQS integration, ensuring compliance with cGMP and global requirements.
Key Responsibilities:- Support the implementation, execution and maintenance of the PQS integration and Quality Documents in Veeva at the Vacaville site.
- Support PQS integration by working with the Quality Document control group to complete workflows, document gating and coordinate elements of the document change process to ensure minimal disruption to site operations
- Support Quality Documents by:
- Initiating and management of documents in Veeva Quality Docs.
- Formating and editing of control documents
- Track and log request of source documents
- Ensure all activities are conducted in compliance with cGMP and global requirements.
- Strive to maintain the highest level of inspection readiness at all times
Key Requirements:- 1-3 years of experience in Quality within the pharmaceutical or biopharmaceutical industry, preferably within a supplier quality function.
- Ability to effectively collaborate within a diverse, cross-functional team.
- On-site presence at the Vacaville location is required.
- Preferred experience with Veeva Quality Document Management System and Microsoft Teams.
- Preferred Technical writing experience
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