SOKOL GxP Services

Supply Chain

• Coordinating supply chain activities between internal planning and Contract Manufacturing Organizations (CMOs)
• Communicating supply and demand information to relevant stakeholders
• Executing and tracking supply and purchase orders to support on-time delivery and customer service levels
• Managing order exceptions, shortages, allocations, and stock-outs
• Maintaining open order reporting and shipping plan communications
• Supporting campaign timing and tolled material consumption
• Coordinating reworks and redress activities at CMO sites
• Assessing and escalating supply disruptions and quality events
• Providing forecasts and input to performance metrics
• Supporting priority planning and special projects
• Escalating issues to the Supply Chain Manager as needed

Production Planner – Supply Chain GMP

Product Marketing

• Lead and manage deviations, investigations, impact assessments, and CAPAs
• Perform root cause analysis (RCA) using formal investigation tools
• Drive timely closure of investigations and CAPAs
• Investigate QC events including OOS (Out-of-Specification) and OOT (Out-of-Trend) results
• Collaborate cross-functionally with QC, Manufacturing, and Quality teams
• Present findings to stakeholders and site leadership
• Apply Quality Risk Management (QRM) principles for decision-making
• Support continuous improvement and operational excellence initiatives

Deviation Investigator – QC, GMP

Learning and Development

• Administer training assignments, curricula, and compliance tasks in the site Learning Management System (LMS), including SuccessFactors.
• Maintain accurate training records, track overdue requirements, and support remediation efforts.
• Partner with QA and functional leaders on onboarding, OJT documentation, and role-based curriculum mapping.
• Develop, revise, and format training materials such as instructor-led training decks, SOP-driven content, and job aids.
• Generate routine and ad-hoc training compliance reports for stakeholders.
• Support continuous improvement initiatives for training processes, documentation quality, and user experience.
• Coordinate training sessions, logistics, communications, and stakeholder reminders.

Production Planner – Supply Chain GMP

Deviation Investigator – QC, GMP

Quality Training Coordinator, GMP/GxP Environment