Lab Operations Specialist

Bachem AG • Vista, CA

3d • $22 - $41

About The Position

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.

Requirements

• 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
• 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

Nice To Haves

• 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)
• Experience with Peptides (preferred)
• Experience with Lean 5S and continuous improvement programs (preferred)

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level