Document Control Specialist

TekWissen LLC

Job Location:

Santa Clara County, CA - USA

Monthly Salary: Not Disclosed

Posted on: 1 hour ago

Vacancies: 1 Vacancy

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

Document Control & QMS Support

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

Change Management (ECO/DEV)

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

Systems & Data Management

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)

Training Coordination

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

Continuous Improvement

Identify inefficiencies and recommend improvements
Participate in QMS and document control improvement initiatives

Collaboration

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.

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 expertis...