Job-ID32727026Reference26-01284Remote50% Remote Job Description: In this role, you will collaborate with cross-functional teams to ensure systems meet quality standards and regulatory requirements through a risk-based approach. This position focuses on maintaining data integrity and system lifecycle management while contributing to operational efficiency. Responsibilities: Apply quality standards and cGMP requirements to validate computer systems, including hardware, software, procedures, and training. Ensure system validation aligns with Data Integrity principles (ALCOA) and includes appropriate testing strategies. Facilitate risk assessments to identify validation deliverables and project requirements. Collaborate with Quality Assurance and other teams to optimize processes such as change management, backup policies, configuration management, and periodic reviews. Develop and execute validation documentation, including requirements, user acceptance testing, SOPs, system impact assessments, traceability matrices, protocols, and reports. Analyze validation data and troubleshoot issues in collaboration with technical teams. Maintain communication with stakeholders to address system needs, validation progress, and related concerns. Requirements: Experience in validation, IT quality assurance, quality control, biomanufacturing, clinical, or regulatory operations. Hands-on experience in validating computerized systems. Strong understanding of pharmaceutical industry regulatory compliance, particularly US and EU/MHRA data integrity guidance. Ability to work effectively in a dynamic, cross-functional team environment. Proven expertise in applying data governance measures and creating impactful data visualizations. Preferred experience with tools and systems such as UPLC, HPLC, HIAC, qPCR, NanoDrop, TOC Analyzer, Osmometer, Cell Counters, and Excel spreadsheet validation. Bachelor's degree in Computer Science, Engineering, Biological Sciences, or a related field.
...Job Description Job Description UPS WORLDSHIP SHIPPER Automation Personnel Services is looking for a UPS WorldShip Shipper for a company based inBartlett,TN.Inthisrole, you willhave the opportunity to take full ownership of the facility's shipping operations...
...Certificate required. Pay rate: $15/hr Shift hours: 3pm to 11pm Job site: Pottsoboro, TX Come to SNELLING to get hired. We have limited spots and will hire qualified candidates, first come, first served. Hiring event: ~423 N. Rusk St., Sherman TX ~06/25/2...
...What we're looking for Bachelor's or Master's degree in Business, Economics, or a related field.Familiarity with BI tools such as Tableau or Power BI.Proficiency with AI tools for analysis and design - you use them daily to work faster and dig deeper.A high degree of...
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OverviewUnder the direct supervision of the Manager, Community Behavioral Health and Substance Use services will provide daily oversight of the Outpatient community mental health program and staff to ensure quality, compliance, and direct service benchmarks are met. Provides...