Document Control Specialist
Job Location:
Santa Clara County, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing scientific expertise and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients Bioscience Biopharmaceuticals Custom manufacturing Biotechnology Life science ingredients Nutrition Microbial Control Agriculture Materials Science Personal Care and cell and gene therapy.
Job Title: Quality System Document Control Administrator
Location: Santa Clara CA - 95054
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday to Friday - First Shift
Summary
The QMS & Document Control Specialist supports the effectiveness of the Quality Management System by managing controlled documentation change processes and training activities in compliance with regulatory requirements. The role ensures audit readiness improves process efficiency and enables cross-functional teams to implement changes accurately within a regulated environment.
Responsibilities
- Manage the full document lifecycle (creation review approval revision distribution archival)
- Ensure documents are accurate complete and compliant
- Conduct periodic document reviews and follow up with owners
- Maintain QMS documentation structure and records
- Administer Engineering Change Order (ECO) processes
- Review submissions for completeness and route approvals
- Coordinate with cross-functional teams for implementation
- Ensure alignment between PLM and ERP systems
- Manage document and part data in PLM systems (Agile preferred)
- Maintain data integrity across PLM ERP and LMS systems
- Generate reports and metrics (ECO status overdue docs training)
- Assign and track training in LMS
- Monitor completion and follow up on overdue training
- Audit & Compliance Support
- Support internal and external audits
- Ensure documentation and records are audit-ready
- Identify inefficiencies and recommend improvements
- Participate in QMS and document control improvement initiatives
- Work with Engineering Manufacturing Quality and other teams
- Guide document owners and ECO initiators on processes
Required Skills
- Associates or Bachelors degree in Business Engineering Life Sciences or related field (or equivalent experience)
- 2 5 years in document control change management or Quality Systems in a regulated environment
- Knowledge of QMS standards (ISO 9001 and/or ISO 13485)
- Experience with PLM systems (Agile preferred) and ERP systems
- Proficiency in Microsoft Office (Word Excel Outlook SharePoint)
- Strong attention to detail and data accuracy
- Ability to manage multiple tasks and meet deadlines
- Strong communication (written and verbal)
- Organizational and coordination skills
- Ability to follow processes and escalate issues when needed
TekWissen Group is an equal opportunity employer supporting workforce diversity.
