Reagent Specialist

Target Pay Rate: 20-28/hr salary will be commensurate with experience.

As part of a dynamic team, the Reagent Change Specialist is responsible for coordinating all change control related activities resulting from supplier product/process change notifications, CAPA, non-conforming events, product obsolescence, or any identified process improvement related changes. The specialist works with requestors and stakeholders to understand the requirements of the change and coordinates all activities through the Change Control Process to implement the changes in the system.

The specialist prioritizes changes based on their impact on manufacturing and product delivery, ensuring timely compliance with quality processes and objectives.

• Work with change requestor to understand requirements of the change and urgency of the change.
• Work with change requestor to identify appropriate approvers for each stage of the change workflow.
• Prioritize change orders that impact reagent production and would otherwise cause manufacturing delays if not implemented.
• Identify impact and dependencies on any other changes needed for that particular document other than what is being requested.
• Ensure the document is on the most current revision of the template and, if not, transfer it to the current revision.
• Align with stakeholders on the timely reviews of document redlines.
• Perform change orders following the appropriate process for the change order type; this may include completion of forms and documents requiring approval on additional change orders.
• Document types can include work instructions (WIs), operating procedures (OPs), production documents, temporary deviations (TDs), stability and surveillance (S&S) memos, technical assessments, protocols, and reports.
• Follow through with approvers to receive approvals in a timely manner.
• Address any comments or concerns from the approvers with change initiators.
• Support change requestor to prepare change control requests for changes that require change control board (CCB) approval.
• Coordinate activities with the Change Management Office (CMO) for implementing changes in the agile system.
• May be part of a change control team to review and assess document changes being made by other groups.

• Embodies the company’s cultural beliefs of People First, Own It, Speak Up, Innovate Now, and Succeed as One.
• Follows Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Continuously promotes Quality First Time.

• Proactively collaborates with peers in other shifts/functions.
• Collaborates with support functions to drive value stream and continuous improvement.
• Participates in tier and staff meetings, as applicable.
• Other duties as assigned by management.

Bachelor's Degree – Required

Master's Degree – Preferred

BS with 4 years of relevant experience in production, manufacturing, supply chain or related field

MS is preferred with 2+ years’ experience.

• Demonstrates potential for technical proficiency, collaboration with others, and independent thought.
• Strong understanding of scientific principles and concepts.
• Applies advanced technical writing skills.
• Excellent oral and written communication skills demonstrated by communicating with other functions.
• Proficient with Google Suite, MS Office, Agile, EtQ, and SAP.
• Excellent time management skills.
• Understanding of manufacturing processes.
• Experience working in a GLP, cGMP, or ISO regulated environment is preferred, but not required.