Quality Control Analyst

3 weeks ago

Malvern, United States Insight Global Full time

Required Skills and Experience:

-Minimum of a Bachelor Degree in science or equivalent technical field

-Minimum of two years of experience working within biological or pharmaceutical system management

-Experience in a Quality Control setting.

-Skilled in basic and advanced knowledge of LIMS systems.

-Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.

-Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols.

-Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).


Nice to Have Skills and Experience:

-Experience with LabVantage eLIMS.

-Experience with electronic systems such as iLAB.

-Technical writing experience


Job Description:

One of our large pharmaceutical clients is looking to hire a QC Lab Analyst -Systems Specialist to support the QC Clinical, Release, and Stability (CRS) Laboratory, Laboratory Method Execution (LME) project and is responsible for local systems management in the QC organization and communication with global workgroups within the systems area. This position requires organizational leadership, interpersonal skills, technological savvy. This position will work cross-functionally and will drive improvements within a global organizational framework.

Responsibilities:

-Supports the LME project via generation of eLIMS assay builds.

-Implements LMEs utilizing Site Key User access to eLIMS.

-Maintains, updates, and manages LMEs, as necessary.

-Support 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.

-Support building and approving MasterData as per the local request.

-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 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 to new users and grant access to system.

-Manage computerized systems administration and user rights.

-Represent the Malvern site in global forums/team meetings as the site key user.

-Support Health Authority inspections.

-Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

-Author, review and approve documents.

-Other duties will be assigned, as necessary.

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