Document Control & Training Specialist

Job Description

Document Control & Training Specialist | Kelly® Science & Clinical

The Tone:
This is a direct-hire leadership role for a specialty pharmaceutical company in Sacramento, CA. The company focuses on bringing the latest scientific discoveries to life within a fast-growing pharmaceutical and biotech organization. This position is crucial for leading teams to manage document control and GMP training programs. The role ensures stringent regulatory compliance, spearheads digital transformation, and fosters strong cross-functional collaboration to cultivate a culture of continuous improvement and operational excellence.

The TL;DR
• Role: Full Time
• Type: Direct Hire
• Location: Sacramento, CA
• Pay: $80000–$90000 yearly
• Team: Leads Document Control and GMP Training teams
• Mission: Ensures regulatory compliance and inspection readiness through effective document control, GMP training, and digital transformation initiatives.
• Tech Stack: Electronic Document Management Systems, Training Management Systems, 21 CFR Part 11, 21 CFR 210/211, EU GMP, GDP, ALCOA

What You’ll Actually Do
• Lead Teams: Direct and mentor Document Control and GMP Training teams, fostering their growth, accountability, and continuous improvement.
• Set Strategy: Establish strategic direction, key performance indicators, and objectives for document control and training programs.
• Ensure Compliance: Champion regulatory compliance by ensuring document management and training meet global requirements and maintain inspection readiness.
• Drive Digital Transformation: Act as the Business System Owner for electronic document and training management systems, overseeing their configuration, validation, and integrity.
• Manage Documentation: Supervise the creation, organization, revision, archival, and retrieval of critical documents for multi-product/multi-site operations.

The Must-Haves
• Background: Bachelor’s degree in Science, Engineering, or a related field; specializing in Quality Assurance within a GMP-regulated environment.
• Experience: 3+ years in QA within a GMP-regulated environment, with demonstrated expertise as a Business System Owner for digital Document Control/Training systems, and proven experience supporting regulatory inspections and customer audits.
• Skills: Extensive knowledge of cGMP (21 CFR 210/211), EU GMP, GDP, 21 CFR Part 11, and ALCOA data integrity principles; superior project management, change leadership, and communication skills.
• Bonus: Master’s degree is strongly preferred.