LABX Validation Lead
Elkton, Virginia, US - 22827 Elkton, VA 22827
Job Title: LABX Validation Lead
Location: Elkton, Virginia, US - 22827
Job Type: Contract
Duration: 6+ Months
About Our Client: Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives
- 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, and/or 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
- 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 Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) 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.
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities
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Recruiter: Jeff Kasula