QA Documentation Specialist I

SGS Consulting; Sacramento (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

SGS Consulting in Vacaville, CA, seeks a Quality professional to support PQS integration and management of Quality Documents within Veeva. This on-site role requires 1–3 years of Quality experience in pharma or biopharma, preferably in supplier quality.

Knowledge of Veeva QDM and strong technical writing skills are a plus. You will collaborate with cross-functional teams to ensure documentation workflows, change control, and regulatory compliance while maintaining readiness for inspections at

Qualifications

• Experience collaborating within a cross-functional team in a regulated biopharma setting.
• On-site presence at Vacaville site is required.
• Preferred experience with Veeva Quality Docs and Microsoft Teams; technical writing is a plus.

Responsibilities

• Support PQS integration by assisting in workflows and approvals at the Vacaville site.
• Support PQS integration by coordinating document change processes with gating and QA teams.
• Initiate and manage documents in Veeva Quality Docs and format/edit control documents.
• Track and log requests for source documents and ensure compliance with cGMP and global requirements.
• Maintain high inspection readiness at all times through disciplined document control.

Skills

Collaboration

On-site presence

Technical writing experience

Tools

Veeva Quality Document Management System

Microsoft Teams

Job description

Job 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

Skills:

• 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

Education/Experience:

1-3 years of experience in Quality within the pharmaceutical or biopharmaceutical industry, preferably within a supplier quality function.