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LABX Validation Lead

Company: HMG America
Location: Reading
Posted on: November 23, 2020

Job Description:

HMG America LLC is the best Business Solutions focused Information Technology Company with IT consulting and services, software and web development, staff augmentation and other professional services. One of our direct clients is looking for LABX Validation Lead in Cherokee, PA. Below is the detailed job description. Position Name LABX Validation Lead Work Location Cherokee, PA Project Duration 6 to 9 months Job Description Job Qualifications 10 years of Lab Systems validation experience is required. Mettler LabX deployment, method development and validation experience (end to end) - pH, balance, titrators, refractometers, melting point and density meters 2 years' experience with LabX method development and validation preferred. Specific hands-on experience with validating, qualifying, andor using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures) Understanding of Data Integrity concepts is required Excellent communication and written skills required Job Responsibilities Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems LabX (Mettler) Author the typical validation, qualification, and testing documentation such as Validation PlansSummaries, Test PlansSummaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQOQPQ) and Scripts, Testing Defects, etc. Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs Coordinate alignment of systems users from various company groups on validation and qualification documentation Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders Act as validation task lead take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.

Keywords: HMG America, Reading , LABX Validation Lead, Other , Reading, Pennsylvania

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