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Scientist Ii Analytical Pdst Change Documentation

Orion Group · United States · Posted 1 hour ago

Company Orion Group Location Lake County, United States Employment type Full-time Posted 1 hour ago Listed via Orion Group
Scientist II - Analytical PDS&T Change Documentation Onsite in Lake County, IL 1 Year Contract Hourly Rate: $47-50/hr (medical benefits available at a cost) We are seeking a detail-oriented Scientist II to support change management and documentation activities within the PDS&T Analytical organization. This onsite role is ideal for a scientific professional with cGMP experience who excels at coordinating cross-functional projects, maintaining compliant documentation, and helping laboratory teams operate efficiently in a highly regulated environment. What are the top 3-5 skills, experience or education required for this position: BS in Scientific Field 3+ years’ experience in a cGMP related environment Good oral, written and presentation skills Strong computer skills Knowledge of change management Job Responsibilities: Create and manage change documentation for PDS&T Analytical organization and other groups within PDS&T.   This will include learning the OneTrack change management system, initiating, managing, overseeing and following up on change management tasks and due dates. Responsibilities may also include redlining and creation of documents (e.g. test methods, standard operating [procedures, etc.) and writing of protocols and reports for test method validations and transfers and for instrument qualifications. This role provides a centralized key support function to allow scientists more time to focus on projects and less time learning systems they seldom or occasionally use.  The person filling this role will be the Subject Matter Expert for OneTrack Change Management for the department. Initiate change requests for commercial products and instruments. Act as project owner, or initiator.  Typical projects include local TMTs, cleaning method validations and instrument qualifications. Serve as Change Coordinator for local change plans or global change plans Work with requestors of change to ensure change proposals are ready for review Facilitate cross functional team meetings with individuals Monitor open change requests and provide visibility to requestors and change managers Accountable for the compliance of the change request documentation to the applicable processes and procedures Responsible for maintaining an accurate, cGMP compliant documentation change control system Qualifications: BS in a scientific field 3+ years’ experience in a cGMP related environment Experience in analytical testing (chromatography, wet chem) preferred but not necessary Ability to work well in a project team environment Good oral, written and presentation skills Strong documentation skills Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, PowerPoint) Knowledge of OneTrack Change Management system is preferred but not necessary. People are our business worldwide Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.
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