Quality Control System Administrator
Bachem AG
Summary
The Quality Control Systems Administrator is responsible for the configuration, maintenance, and support of the Laboratory Information Management System (LIMS), ensuring it meets operational, regulatory, and data integrity requirements. This role supports QC laboratory workflows by interfacing with analytical software (e.g., Chromeleon, Empower), laboratory instrumentation, and enterprise systems, helping to optimize efficiency, accuracy, and compliance.
Job description
What you will do
- 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.
Qualifications
- Bachelor’s degree in life sciences or other relevant discipline
- 3+ years of experience with LIMS platforms (e.g., LabWare, STARLIMS, LabVantage) Req and
- Hands-on experience with analytical software used in QC labs (Chromeleon, Empower, etc.) and integrating such systems with LIMS.
- Strong understanding of GxP, GMP, and FDA regulatory requirements in a QC laboratory environment.
- 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.
Requirements
- Bachelor’s degree in life sciences or other relevant discipline
- 3+ years of experience with LIMS platforms (e.g., LabWare, STARLIMS, LabVantage)
- Hands-on experience with analytical software used in QC labs (Chromeleon, Empower, etc.) and integrating such systems with LIMS
- Strong understanding of GxP, GMP, and FDA regulatory requirements in a QC laboratory environment
- 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
Benefits
- Competitive pay
- Annual performance bonus
- Medical, Dental & Vision
- 401(k) plan
- Employer contribution
- Paid vacation
- Personal days
- Sick days
Company overview
Bachem AG is a leading Swiss biotechnology company specializing in the development and manufacturing of peptides and oligonucleotides. Founded in 1971 and headquartered in Bubendorf, Switzerland, the company has grown to become a global leader in the field with over 50 years of expertise. Bachem operates internationally with production facilities in Switzerland, the United States, and the United Kingdom, serving pharmaceutical and biotechnology companies worldwide. The company provides comprehensive services spanning from research-grade products to GMP manufacturing for clinical development and commercial applications. Bachem's product portfolio includes peptide new chemical entities (NCEs), oligonucleotide NCEs, commercial APIs, research chemicals, and diagnostic products. As a publicly traded company listed on the SIX Swiss Exchange, Bachem employs approximately 2,200 professionals globally and maintains a strong reputation for quality, innovation, and regulatory compliance in the pharmaceutical manufacturing sector.