Document Control Specialist

TekWissen LLC

Santa Clara, CA

JOB DETAILS
SALARY
$24–$28
LOCATION
Santa Clara, CA
POSTED
7 days ago

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

  • Associate's or Bachelor's 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.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/