Quality Control System Administrator

Bachem Holding AG; California; Presencial; USD 88 000 - 123 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical/Dental/Vision coverage

401(k) plan with employer contribution

Paid vacation, personal and sick days

Resumo da oferta

Bachem Americas is seeking a Quality Control Systems Administrator to configure, maintain, and support the LIMS, ensuring regulatory compliance and data integrity across QC workflows.

You will collaborate with QC analysts, IT, and QA, manage master data, and drive instrument-LIMS integrations to optimize efficiency. Strong CSV, SQL, and communication skills are required.

Qualificações

• 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 used in QC labs (Chromeleon, Empower) 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.

Responsabilidades

• 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 (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.

Conhecimentos

SQL proficiency

Analytical thinking

Communication skills

Formação académica

Bachelor’s degree in life sciences or related discipline

Ferramentas

LabWare

STARLIMS

LabVantage

Chromeleon

Empower

Descrição da oferta de emprego

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com .

A brief overview

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.

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.

Base salary range: $88,480 - $123,036

Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

At Bachem, you’ll find a diverse, multicultural team. The (a)in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation.

Please note: unsolicited resumes from recruitment agencies will not be considered.