Role Impact
The Laboratory Application Scientist ensures the performance, compliance, and validation of all laboratory systems supporting quality control operations. This role is integral to maintaining audit-readiness and system reliability across chemistry and microbiology labs, and requires a strong understanding of lab technologies, software, and GMP processes. Success is defined by effective management of laboratory instruments, software platforms, and data workflows in a regulated environment.
Key Responsibilities
- Manage lifecycle of laboratory computerized systems, including software upgrades, user training, and audit trail reviews
- Provide technical oversight and support for lab instrumentation and software integration
- Maintain laboratory calibration, qualification, and metrology schedules, including vendor coordination
- Lead or support LIMS administration, method configuration, and access management
- Author and maintain validation, SOPs, deviation reports, and calibration documentation
- Participate in lab audits, drive CAPA execution, and improve compliance processes
- Evaluate and implement new lab instruments and technologies in alignment with user requirements
- Collaborate across QA, IT, and lab teams to ensure efficient data handling and regulatory readiness
Essential Qualifications
years of experience in QC or development labs in pharma or medical device industriesProficient with lab informatics and instrumentation platforms (, HPLC, LCMS, ICP, GC)Demonstrated expertise with lab technology systems, including control software and LIMSWorking knowledge of GMP, cGMP, FDA data integrity guidelines, and validation practicesAbility to author and review CAPA, deviations, protocols, and technical documentationClinical Skill Set
CAPA implementation
Data integrity complianceHPLCInstrument qualificationLab software platformsLCMSLIMSMetrology programsSOP writingValidation protocolsPreferred Skills
Direct experience supporting lab software and hardware integrationsBackground managing or mentoring small teams or lab projectsProficiency in Microsoft Excel and Word for documentation, audits, and reportingEEO / ADA Statement
We are an equal opportunity employer and provide reasonable accommodations upon request.
Location
Onsite | Remote not specified
Compensation & Schedule
yearFull-time hoursW EmploymentStart Date : ASAP