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Skills
Analysis Skillsunmatched
Change Managementunmatched
Change Requests/Ordersunmatched
Chromatographic Assayunmatched
Communication Skillsunmatched
Computer Skillsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Document Change Managementunmatched
Documentationunmatched
Microsoft Excelunmatched
Microsoft PowerPointunmatched
Microsoft Product Familyunmatched
Microsoft Wordunmatched
Organizational Skillsunmatched
Presentation/Verbal Skillsunmatched
Quality Assurance Methodologyunmatched
Standard Operating Procedures (SOP)unmatched
Team Playerunmatched
Description
Duration: 12 months Contract
Job Description:
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.
Skills:
Experience in analytical testing (chromatography, wet chem) preferred but not necessary.
Ability to work well in a project team environment.
Communication 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.
Top skill requirements:
BS in Scientific Field.
3+ years’ experience in a cGMP related environment.
Good communication and presentation skills.
Strong computer skills.
Knowledge of change management.
Education and experience:
BS in a scientific field.
3+ years’ experience in a cGMP related environment.
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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