Digital Quality Assurance Analyst

Spectraforce Technologies
United States, Massachusetts, Worcester
Feb 25, 2025
Job title: Digital Quality Assurance Analyst Work Location: Worcester, MA 01605 Duration: 9 months (possible extension) Work Schedule: Monday to Friday, hybrid schedule with 2-3 days onsite. Description: The role focuses on the quality assurance of digital systems in a biotech environment The role involves reviewing static data, ensuring system builds are correct, configuring data with the guidance of senior analysts, and troubleshooting where possible. The candidate will work within SAP, Sample Manager (LIMS), and Thermal LIMS. The focus is on data configuration, review, and quality assurance within digital systems. Responsibilities include reviewing and configuring static data to ensure accuracy, troubleshooting issues when possible, and working with senior analysts and source documentation to generate and validate system data. The candidate will not be performing any lab assays or direct testing but will be responsible for building, reviewing, and configuring data within digital quality systems. No coding is required; all tasks are done through a user interface. The candidate will troubleshoot data configuration issues when possible, but more advanced troubleshooting will be handled by senior team members. Independently Executes System Configuration based on pre-defined requirements provided by SME's Understand/maintain a safe work environment for themselves and others Understands, implements and maintains strong GMP's with respects to Quality Digital Systems Adaptable to changing priorities Responsible for ownership of routine tasks as established by management (I.e data archival, account creation, document relationships etc). Performs review of executed system configurations and ensures accuracy of completed work. Accepts responsibility to complete assigned tasks, works with others to maintain a positive atmosphere and accomplish business objectives. Top skills: 3-5 years of experience in Biotech. (QC Labs, Operations or QA) Familiarity with quality systems in biotech (experience in a biotechnology or pharmaceutical quality environment is acceptable). Knowledge of SAP, Sample Manager, Excell, Microsoft word Excellent communication, organization, time-management and teamwork skills What we are looking for: Strong knowledge of GMP labs and how biotech production environments function. The primary systems used are SAP, Sample Manager (LIMS), and Thermal LIMS. Candidates must have strong computer skills, including Excel, Word, and Visio. Ideal candidates may have backgrounds as Lab Analysts (Analytical or Microbiology) or Manufacturing Technicians. Education Requirement: Associate degree is acceptable. Strong GMP lab experience and familiarity with bioprocessing operations. Proficiency in Microsoft Excel, Word, and Visio. Ability to configure and review system data for accuracy based on source documentation. Strong organizational, communication, and time-management skills. No, data visualization is not needed. The focus is on navigating quality systems, cross-referencing source documentation, and ensuring accuracy in digital records.