Change Control Specialist

Reagent Change Specialist

We are seeking a highly organized and detail-oriented Reagent Change Specialist to support change control activities within a regulated manufacturing environment. This role is responsible for coordinating and managing change control processes resulting from supplier notifications, CAPAs, non-conformances, product obsolescence initiatives, and continuous improvement activities.

The successful candidate will partner with cross-functional stakeholders to assess change requirements, facilitate approvals, prioritize production-impacting changes, and ensure timely implementation while maintaining compliance with quality and regulatory requirements.

Key Responsibilities

Production Change Control

• Coordinate change control activities related to manufacturing and reagent production.
• Collaborate with change requestors to understand change requirements, urgency, and business impact.
• Identify appropriate reviewers and approvers throughout the change workflow.
• Prioritize change orders impacting production schedules and product delivery.
• Assess document dependencies and ensure alignment with current templates and revision controls.
• Facilitate stakeholder reviews and track approvals to ensure timely completion.
• Support preparation and execution of change control requests requiring Change Control Board (CCB) approval.
• Coordinate implementation activities with Change Management teams and system administrators.
• Review and assess document modifications across functional groups as needed.

Documentation & Quality

• Manage updates to controlled documents including SOPs, Work Instructions, Production Documents, Technical Assessments, Protocols, Reports, Deviations, and Stability Documentation.
• Ensure compliance with GMP, GDP, and company quality standards.
• Support Quality First Time initiatives and continuous improvement activities.

Collaboration

• Work closely with Manufacturing, Quality, Supply Chain, Engineering, and other stakeholders.
• Participate in team meetings and continuous improvement initiatives.
• Support organizational goals through effective communication and project coordination.

Qualifications

Required

• Bachelor’s Degree in a scientific, engineering, manufacturing, supply chain, or related discipline.
• Minimum 4 years of experience in manufacturing, production, quality, supply chain, or a related field.
• Experience working within GMP, GLP, ISO, or other regulated environments.
• Strong technical writing and documentation skills.
• Excellent communication and organizational abilities.
• Proficiency with Microsoft Office and Google Workspace.

Preferred

• Master’s Degree in a related discipline.
• Experience with Agile PLM, EtQ, SAP, or similar quality systems.
• Knowledge of CAPA, deviations, supplier change notifications, and document control processes.
• Understanding of manufacturing operations and quality management systems.