Laboratory Application Specialist

Experteer Overview In this role you implement, support, and optimize BioA laboratory software and data management across Frontage’s BioA labs. You will lead software validation, instrument integration, and data integrity to ensure compliant, efficient operations. You will collaborate with Corporate IT and lab teams to drive improvements and enforce 21 CFR Part 11 compliance. This is an opportunity to shape how software supports scientific work in a fast-growing CRO with global reach. Compensation / Benefits * Provide instrument qualification, software validation, and administration for lab instruments and related software * Configure lab software to align with instrument integrations and workflows * Document software changes, upgrades, and validation activities * Identify and implement technology improvements to boost efficiency and compliance * Contribute to change controls and lab software procedures * Coordinate with vendors on site and serve as liaison between Corporate IT and lab groups * Manage data integration across instruments and computer systems * Provide user training on software access and functionality * Maintain software validation status in compliance with 21 CFR Part 11 * Perform other duties as assigned Tasks * Bachelor’s degree in a relevant scientific, engineering, or computer-based area * 3 years’ experience in the pharmaceutical industry or equivalent IT/lab experience * Knowledge of GXP regulatory requirements and 21 CFR Part 11 data integrity * Experience with Watson, IDBS, Analyst, and other analytical lab software; Microsoft Office applications * GxP experience * Strong organization, planning, and communication skills Key requirements * health and dental insurance * 401(k) plan * disability insurance * life insurance

Experteer Overview In this role you implement, support, and optimize BioA laboratory software and data management across Frontage’s BioA labs. You will lead software validation, instrument integration, and data integrity to ensure compliant, efficient operations. You will collaborate with Corporate IT and lab teams to drive improvements and enforce 21 CFR Part 11 compliance. This is an opportunity to shape how software supports scientific work in a fast-growing CRO with global reach. Compensation / Benefits * Provide instrument qualification, software validation, and administration for lab instruments and related software * Configure lab software to align with instrument integrations and workflows * Document software changes, upgrades, and validation activities * Identify and implement technology improvements to boost efficiency and compliance * Contribute to change controls and lab software procedures * Coordinate with vendors on site and serve as liaison between Corporate IT and aB _ groups * Manage data integration across instruments and computer systems * Provide user training on software access and functionality * Maintain software validation status in compliance with 21 CFR Part 11 * Perform other duties as assigned Tasks * Bachelor’s degree in a relevant scientific, engineering, or computer-based area * 3 years’ experience in the pharmaceutical industry or equivalent IT/lab experience * Knowledge of GXP regulatory requirements and 21 CFR Part 11 data integrity * Experience with Watson, IDBS, Analyst, and other analytical lab software; Microsoft Office applications * GxP experience * Strong organization, planning, and communication skills Key requirements * health and dental insurance * 401(k) plan * disability insurance * life insurance