Potency QC Analyst I — GMP Biotech Lab

Bayer (Schweiz) AG; Berkeley (CA); On-site; USD 67,000 - 100,000; Full time

Benefits offered by this job

Health care

Vision insurance

Dental

Job summary

Bayer in Berkeley, CA is seeking a QC Potency Analyst I to ensure potency, quality, and reliability of biologic products through GMP-regulated testing in a busy lab, including in-process control, release, and stability testing on graveyard shift.

You will prepare samples, operate instruments, document data in LIMS/SAP, and support deviations/investigations while ensuring safety and data integrity. Bachelor-level life sciences required; up to two years of lab experience preferred.

Qualifications

• Bachelor's degree in biology, biochemistry, chemistry, medical laboratory science, pharmaceutical science, or related field.
• Foundational knowledge of core laboratory practices, including calculations, solution preparation, pipetting, and safe handling of materials.
• Ability to follow detailed written procedures and document activities in controlled records.
• Experience using computers and validated laboratory software; familiarity with LIMS and SAP.
• Clear verbal and written communication; ability to escalate questions and observations.
• Reliability, adaptability, and ability to work independently and in a graveyard-shift team.

Responsibilities

• Perform routine potency and related analytical testing following approved methods, specifications, SOPs, and cGMP.
• Prepare samples, reagents, standards, controls, and equipment; maintain readiness of work areas.
• Operate laboratory instruments and automated systems with required qualification; perform basic troubleshooting.
• Document activities and results contemporaneously in controlled records and LIMS/SAP; review data for completeness.
• Assist with discrepancy investigations and data collection within established timelines.
• Follow safety requirements for handling biological materials, chemicals, sharps, and waste; uphold data integrity.

Skills

Laboratory experience

Attention to detail

Data integrity

Verbal and written communication

Education

Bachelor's degree in biology/chemistry/pharmaceutical science

Tools

LIMS

SAP

Job description

Bayer in Berkeley, CA is seeking a QC Potency Analyst I to ensure potency, quality, and reliability of biologic products through GMP-regulated testing in a busy lab, including in-process control, release, and stability testing on graveyard shift.

You will prepare samples, operate instruments, document data in LIMS/SAP, and support deviations/investigations while ensuring safety and data integrity. Bachelor-level life sciences required; up to two years of lab experience preferred.