Specialist, Quality Control

The Role

The Specialist, Quality Control will serve as a key contributor to the digital transformation of QC processes, supporting AI-driven initiatives and support of enterprise Lab Systems. The Specialist will collaborate with QC and Digital teams to meet business objectives and assist in the configuration and deployment of Digital systems in QC as needed.

• Provide day‑to‑day support for QC laboratory systems, including LIMS, Chromeleon, and other enterprise laboratory applications, ensuring reliable system performance and timely issue resolution.
• Perform routine system administration activities, including user access management, configuration updates, software maintenance, and coordination of system installations and upgrades with Digital teams.
• Serve as the primary Tier 1 support resource for laboratory computer systems, troubleshooting system issues, documenting resolutions, and escalating complex issues as appropriate.
• Support implementation, testing, and deployment of system enhancements, software updates, and new functionality to meet QC business needs.
• Author, revise, and maintain equipment, software, business administration, and system lifecycle documentation, including SOPs, work instructions, and training materials.
• Support quality system activities related to laboratory software, including deviations, change controls, CAPAs, periodic reviews, and validation documentation, ensuring compliance with GMP and Data Integrity (ALCOA+) requirements.
• Train and support QC personnel on laboratory software and system functionality, providing guidance on system use and best practices.
• Participate in continuous improvement initiatives by identifying opportunities to simplify processes, improve system utilization, and enhance the user experience.
• Support the development, implementation, and continuous improvement of AI-powered and digital solutions that enhance Quality Control laboratory operations, including data review, trending, reporting, and workflow automation.
• Partner with QC, Digital, and Automation teams to translate business needs into scalable AI-enabled solutions and integrate new technologies into existing QC systems.
• Ensure AI and digital capabilities comply with GMP requirements, Data Integrity (ALCOA+) principles, and applicable regulatory expectations, including supporting validation, change control, and quality documentation.
• Monitor the performance and adoption of AI and digital tools, identify opportunities for optimization, and provide training and guidance to QC personnel on new technologies.
• Collaborate with internal stakeholders, including IT, Digital, and Regulatory teams, to ensure alignment with corporate AI strategies.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

• Education:
  
  BS in Sciences or relevant scientific field
• Experience:
  
  3-5 years of experience in the biotechnology/biopharmaceutical industry, preferably in a QC, Digital, or Automation role. Familiarity with AI applications, data analysis tools, and digital solutions in a GMP environment is preferred.
• Understanding of laboratory informatics systems (e.g., LIMS, Chromatography Data Systems) is a plus.
• Specific Certifications or Training:
  None
• Other Quantifiable Preference:
  Strong problem‑solving skills and…