LIMS Administrator: QC Data & Compliance Specialist

Bachem Americas, Inc.; Vista (CA); Sur place; USD 88 000 - 123 000; Plein temps

Avantages offerts par ce poste

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Annual performance bonus

Résumé du poste

Bachem Americas, Inc. is seeking a LIMS Administrator to configure, maintain, and support the Laboratory Information Management System (LIMS).

You will collaborate with QC, IT, and QA to ensure GxP, GMP, and FDA compliance, manage master data and workflows, and integrate LIMS with lab instrumentation to enhance data integrity. You will also contribute to validation, change control, and audit readiness, and develop documentation such as URS, OQ, PQ, and SOPs while supporting end users with

Qualifications

• Bachelor’s degree in life sciences or related field.
• 3+ years of LIMS experience (LabWare, STARLIMS, LabVantage).
• Hands-on Chromeleon/Empower experience; integrate with LIMS.
• Strong GxP, GMP, FDA regulatory knowledge in QC labs.
• Experience with CSV documentation and validation.
• Proficient SQL, data management, and reporting.
• Excellent problem-solving, organization, and communication.
• Capable of independent work and prioritizing in fast-paced settings.
• Familiar with pharma/biotech QC workflows and ERP/ELN integration.
• Experience leading or supporting system upgrades.

Responsabilités

• Administer, configure, and maintain the LIMS platform including upgrades.
• Collaborate with QC, IT and QA to ensure GxP compliance and FDA readiness.
• Configure master data, workflows, and user accounts in LIMS.
• Support staff with LIMS/instrument software issues and provide end-user training.
• Integrate LIMS with lab instrumentation and QC software to streamline workflows.
• Develop and maintain URS, OQ, PQ, SOPs, and related documentation.
• Participate in system validation, change control, and audit readiness.
• Create and manage reporting formats, queries, and data analysis tools (SQL).
• Conduct periodic audits to identify improvements and ensure data integrity.
• Coordinate calibrations, maintenance, and resolve system-related issues.
• Benchmark best practices and contribute to continuous improvement.

Connaissances

Problem solving

Organizational skills

Communication skills

Independent work

Multi-priority management

GxP knowledge

FDA regulatory knowledge

CSV experience

SQL proficiency

Analytical instrumentation

Formation

Bachelor's degree in life sciences

Outils

LabWare

STARLIMS

LabVantage

Chromeleon

Empower

Description du poste

Bachem Americas, Inc. is seeking a LIMS Administrator to configure, maintain, and support the Laboratory Information Management System (LIMS).

You will collaborate with QC, IT, and QA to ensure GxP, GMP, and FDA compliance, manage master data and workflows, and integrate LIMS with lab instrumentation to enhance data integrity. You will also contribute to validation, change control, and audit readiness, and develop documentation such as URS, OQ, PQ, and SOPs while supporting end users with