We are seeking a detail-oriented Reagent Change Control Specialist to support change management activities within a regulated manufacturing environment. This role is responsible for coordinating and implementing change controls resulting from supplier changes, CAPAs, non-conformances, product obsolescence, and continuous improvement initiatives.
The ideal candidate will collaborate with cross-functional stakeholders to assess change requirements, coordinate approvals, manage documentation updates, and ensure compliance with GMP and quality system requirements. This position requires strong organizational skills, technical writing abilities, and experience working in regulated environments.
Key Responsibilities
- Coordinate change control activities from initiation through implementation.
- Collaborate with requestors and stakeholders to define change requirements and approval workflows.
- Prioritize changes impacting manufacturing operations and product delivery.
- Assess document impacts, dependencies, and revision requirements.
- Manage updates to SOPs, work instructions, production documents, technical assessments, protocols, reports, and deviations.
- Track approvals and follow up with stakeholders to ensure timely completion.
- Support Change Control Board (CCB) activities and change management processes.
- Ensure compliance with GMP, GDP, and quality system requirements.
- Participate in continuous improvement initiatives and cross-functional projects.
Qualifications
- Bachelor's degree required; Master's degree preferred.
- 2–4+ years of experience in manufacturing, production, quality, supply chain, or related fields.
- Experience in GMP, cGMP, GLP, ISO, or other regulated environments preferred.
- Strong technical writing, documentation, and communication skills.
- Experience with Agile, ETQ, SAP, Microsoft Office, or similar systems is preferred.