Reagent Change Specialist

• Coordinate and manage change control activities related to supplier product/process changes, CAPAs, non-conforming events, product obsolescence, and continuous improvement initiatives.
• Partner with cross-functional stakeholders to assess change requirements, prioritize implementation activities, and ensure compliance with quality and regulatory standards.
• Update and revise documents including Work Instructions, Operating Procedures, Production Documents, Temporary Deviations, Stability & Surveillance Memos, Technical Assessments, Protocols, and Reports using current templates and revision controls.
• Facilitate stakeholder review and approval processes, track approvals, and address reviewer comments.
• Support preparation of Change Control Board (CCB) requests and coordinate implementation activities with the Change Management Office (CMO).
• Participate in cross-functional change control review teams as needed.
• Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), ensuring compliance with quality systems and regulations.
• Collaborate with cross-functional teams, support continuous improvement initiatives, and contribute to team and departmental meetings.
• Perform additional duties as assigned.

Do you have experience in Technical writing within manufacturing?, Do you have a Bachelor's degree?, * Bachelor's Degree in a scientific, manufacturing, supply chain, or related discipline.

• 4+ years of experience in production, manufacturing, supply chain, quality, or a related field; Master's Degree with 2+ years of relevant experience preferred.
• Strong understanding of scientific principles and manufacturing processes.
• Advanced technical writing and documentation skills.
• Excellent verbal and written communication abilities.
• Strong organizational and time management skills.
• Ability to work independently and collaboratively across functions.
• Proficiency with Google Suite, Microsoft Office, Agile, EtQ, SAP, experience managing document control and change management processes.
• Experience in GLP, cGMP, or ISO-regulated environments preferred.

Pulled from the full job description

• 401(k)
• Health insurance
• Vision insurance
• Dental insurance
• Life insurance

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.