Lab Operations Specialist at Bachem Americas, Inc. – Vista, California

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status
Bachem Americas, Inc.

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 Lab Operations Specialist supports daily quality control activities by managing key laboratory functions such as sample control, equipment coordination, reference standards, stability programs, and retain management. This role ensures smooth lab operations and adherence to regulatory requirements, while contributing to problem solving and continuous improvement within the QC environment.

What you will do

• Oversee the daily operations of the Quality Control laboratory by ensuring efficient workflows, including equipment readiness, 5S compliance, sample management (API, stability, retains, reference standards), and the availability of laboratory supplies and consumables, while maintaining strict adherence to safety and regulatory standards.
• Ordering supplies and maintaining adequate stock of other consumable items. Dispositioning QC lab generated waste.
• Oversee the calibration and preventative maintenance (PM) of laboratory instruments (e.g., HPLC, UPLC, LC-MS, IC, GC, Balances, UV-Vis, Karl Fischer).
• Responsible for documenting and shipping samples to external labs and timely follow up on the results and cost analysis regarding lab quotes
• Monitor and keep up-to-date RS inventory card, column tracking logs, RS internal tracking log, equipment usage log/maintenance logbook, etc.)
• Act as the subject matter expert (SME) on laboratory instrumentation, ensuring that all analytical instruments and equipment in a Quality Control laboratory are properly calibrated, qualified, and maintained in compliance with Current Good Manufacturing Practices (cGMP).
• Act as the primary contact for technical troubleshooting and repairs of laboratory instruments, often coordinating with external vendors. Ensure all calibration records, maintenance logs, and instrument qualification reports comply with FDA, EMA, and internal cGMP/GLP standards
• Provide training and guidance to lab analysts on the proper use and operation of analytical equipment as necessary.
• Maintain an inventory of spare parts and ensure equipment readiness for laboratory testing.

Qualifications

• Bachelor's degree in chemistry or related life sciences field or
• High School diploma with 7+ years relevant experience
• 3+ years' experience in a Quality Control GMP environment
• Hands-on experience in maintaining and troubleshooting instruments (especially HPLC, GC, LC-MS, IC, Karl Fischer, Balances etc.,)
• 1 year of experience in performing or overseeing IQ/OQ/PQ for analytical instruments, vendor management for service contracts, change controls, and equipment lifecycle documentation
• Knowledge of USP/ NF, EP, JP and ICH deadlines (preferred)
• Ability to routinely work with hazardous materials and manage hazardous waste in a satellite accumulation area (preferred)
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one's time
• Communicate effectively and ability to function well in a team environment
• Flexibility of working hours based on business needs, may include nights and occasional weekends
• Experience with Peptides (preferred)
• Experience with Lean 5S and continuous improvement programs (preferred)

Base Hourly Ranges:

Specialist: $22.11 - $30.40

Sr. Specialist: $29.79 - $40.95

Placement of new hires in these wage ranges 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.