Job Details

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

As part of a dynamic team, the Reagent Change Specialist main responsibilities include coordinating all change control related activities resulting from either a supplier product/process change notification, a CAPA, a non-conforming event, a product obsolescence, or any identified process improvement related changes.

The Reagent Change Specialist will work with the change requestor and appropriate stakeholders to understand the requirements of the change and will then coordinate all activities with the Change Control Process to follow through and implement the changes in the system. Individual will also work on prioritization of the changes depending on the impact on the manufacturing and product delivery. The individual will have excellent communication and organizational skills, and the ability to identify opportunities that would drive the business forward while complying with quality processes and objectives.

Production Change Control
? 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 stages of the change workflow.
? Prioritizes change orders that impact reagent production and would otherwise cause manufacturing delays if not implemented.
? Identifies impact and dependencies on any other changes needed for that particular document other than what is being requested.
? Ensures document is on the most current revision of the template and if not, then transfers it to the current revision.
? Aligns with stakeholders on the timely reviews of document redlines.
? Performs 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.
? Addresses 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.

Compliance & Quality
? 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.

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

Education
Bachelors Degree – Required
Masters Degree – Preferred

Experience
BS with 4 years of relevant experience in production, manufacturing, supply chain or related field
MS is preferred with 2+ years’ experience.

Knowledge, Skills & Abilities
? 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.