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.