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QA Documentation Specialist I

Sunrise Systems Inc

Vacaville, CA

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JOB DETAILS
SKILLS
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
Vacaville, CA
POSTED
5 days ago
Job Title: QA Documentation Specialist
Job ID: 26-02786
Location: Vacaville, CA
Duration: 6 Months
M-F 5x onsite 1st shift (8 am - 5 pm)

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
Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com

About the Company

S

Sunrise Systems Inc

Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.

We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.

Our collective business experience spans over two and a half decades and ranges from:

  • Business, management, and technical fields
  • Information technology consulting and software solutions.
  • Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
  • Motivating technology staff and establishing partnerships with Fortune 500 companies

Sunrise Systems has a vast range of competence in:

  • Design, development, and support of cloud-based solutions from simple to highly complexed
  • Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
  • Data processing and data migration
  • Application re-engineering and platform migration
  • Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1990
WEBSITE
http://www.sunrisesys.com/