LIMS & QC Systems Administrator — GxP/FDA Ready

Bachem Americas, Inc.; Vista (CA); On-site; USD 88,000 - 123,000; Full time

Benefits offered by this job

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation

Job summary

Bachem Americas, Inc. is seeking a Quality Control Systems Administrator to manage the LIMS and ensure regulatory compliance across QC workflows in our Vista, CA facility.

The role focuses on configuring and maintaining LIMS (LabWare/STARLIMS/LabVantage), interfacing with Chromeleon and Empower, and supporting data integrity, CSV validation, and system upgrades in a fast-paced pharma environment.

Qualifications

• Bachelor's degree in life sciences or related discipline.
• 3+ years of experience with LIMS platforms (LabWare, STARLIMS, LabVantage).
• Hands-on experience with analytical software (Chromeleon, Empower) and integrating such systems with LIMS.
• Strong understanding of GxP, GMP, and FDA regulatory requirements in QC lab.
• Experience with computer system validation (CSV), including documentation and audit readiness.
• Proficiency in SQL, data management, and report generation.
• Excellent problem-solving, organizational, and communication skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.
• Familiarity with pharmaceutical/biotech laboratory workflows (release testing, stability, method validation).
• Knowledge of integration with ERP or ELN systems.
• Experience leading or supporting system upgrade or enhancement projects.
• Strong background in QC operations and analytical instrumentation.

Responsibilities

• Administer, configure, and maintain the LIMS platform, including upgrades, troubleshooting, and performance optimization.
• Collaborate with QC analysts, IT, and QA to ensure LIMS and associated systems comply with GxP, GMP, and FDA regulations.
• Configure and manage master data, workflows, and user accounts within LIMS.
• Support laboratory staff with LIMS- and instrument-software–related issues; provide training and guidance to end users.
• Integrate LIMS with laboratory instrumentation and QC software (e.g., Chromeleon, Empower) to streamline workflows and ensure data integrity.
• Develop, review, and maintain documentation (e.g., URS, OQ, PQ, SOPs, policies, protocols).
• Participate in system validation, change control, and audit readiness activities.
• Create and manage reporting formats, queries, and data analysis tools (SQL, custom reports).
• Conduct periodic audits and reviews to identify issues, ensure compliance, and recommend improvements.
• Monitor equipment/software performance, coordinate calibrations and preventive maintenance, and support resolution of system-related issues.
• Benchmark best practices, identify trends, and contribute to continuous improvement of laboratory data management systems.

Skills

Problem-solving

Communication

Organizational skills

Independence

Education

Bachelor's degree in life sciences or related discipline

Tools

LabWare

STARLIMS

LabVantage

Chromeleon

Empower

SQL

Job description

Bachem Americas, Inc. is seeking a Quality Control Systems Administrator to manage the LIMS and ensure regulatory compliance across QC workflows in our Vista, CA facility.

The role focuses on configuring and maintaining LIMS (LabWare/STARLIMS/LabVantage), interfacing with Chromeleon and Empower, and supporting data integrity, CSV validation, and system upgrades in a fast-paced pharma environment.