Required Skills & Experience
-A minimum of a bachelor’s degree in science or equivalent technical field is required.
-A minimum of two (2) years of experience within a biological and/or pharmaceutical industry or equivalent.
-2-5 years of experience with advanced knowledge of LIMS systems – strongly preferred LabVantage
-Experience in a Quality Control setting.
-Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems
-Proficient in performing technical writing
-Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
-Proficient with Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
Job Description
The QC Lab Services Analyst, Systems specialist, position supports the overall QC organization and is responsible for local systems management in the QC organization and communication with global work groups within the systems area. This position requires organizational leadership, interpersonal skills, technological savvy, and technical writing skills. This position will work cross-functionally and will drive improvements within a global organizational framework.
Responsibilities:
-Support building and approving MasterData as per the local request
-Process LIMS change control requests
-Manage the LIMS change control process through timely resolution of incident tickets.
-Works with the laboratory personnel to optimize LIMS functions for the laboratory
-Coordinate system maintenance downtime needs between user community and system support personnel.
-Lead and mentor on best practices regarding data integrity
-Provide first level diagnosis and troubleshooting of incidents to support business users.
-Lead cross-functional meetings to track the status of LIMS, change requests and project status.
-Provides end-to-end support for tickets requiring system change (requirements gathering, documentation updates, development, system configuration, validation protocol/script development to validation execution).
-Provide training for new users and grant access to the system
-Manage computerized systems administration and user rights
-Support Health Authority inspections
-Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
-Author, review and approve documents
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