QC Potency Analyst I - Berkeley, CA

Your Tasks and Responsibilities

• Perform routine potency and related analytical testing in accordance with approved methods, specifications, SOPs, and cGMP requirements to support in-process, release, stability, and special testing during graveyard-shift operations
• Prepare samples, reagents, standards, controls, and laboratory equipment required for assigned testing, and maintain laboratory readiness through cleaning, inventory checks, reagent and supply preparation, and organization of assigned work areas
• Operate laboratory instruments and automated systems after completion of required training and qualification, performing routine checks, cleaning, and basic troubleshooting to ensure reliable performance and data integrity
• Document activities and results contemporaneously, accurately, and legibly in controlled records and approved electronic systems, including LIMS or other laboratory databases, and review test data for completeness while promptly reporting deviations, atypical observations, instrument issues, or other abnormalities to appropriate colleagues
• Initiate or support laboratory discrepancy and investigation records as assigned, including collection of relevant data and completion of required documentation within established timelines in alignment with GMP and inspection-readiness expectations
• Follow laboratory safety requirements, including appropriate handling of biological materials, chemicals, sharps, and laboratory waste, and uphold quality, safety, and data-integrity standards in all aspects of daily work
• Manage multiple assignments and changing priorities while maintaining data integrity, quality, and schedule commitments, completing required training and progressively qualifying on QC Potency methods, systems, and supporting laboratory processes
• Provide clear shift handoffs and communicate testing status, issues, and follow-up needs to graveyard and day-shift colleagues, participating in continuous-improvement, inspection-readiness, and team activities that enhance QC Potency performance and support the broader site quality goals

Required Qualifications

• Entry-level professional mindset with up to two years of laboratory experience in an academic, biotechnology, pharmaceutical, or cGMP environment, or equivalent hands-on laboratory training that demonstrates readiness to contribute in a regulated QC setting
• Bachelor's degree in biology, biochemistry, chemistry, medical laboratory science, pharmaceutical science, or a related scientific discipline, or an equivalent combination of education and relevant laboratory training
• Foundational knowledge of core laboratory practices, including calculations, solution preparation, pipetting, and safe handling of laboratory materials, along with the ability to follow detailed written procedures and accurately document laboratory activities and results in controlled records
• Comfort using standard computer applications and learning validated laboratory software and automated instrumentation, with the ability to work within electronic systems such as LIMS and SAP in alignment with cGMP and data-integrity principles
• Attention to detail and a consistent commitment to quality, safety, and data integrity, coupled with the ability to learn technical procedures, accept feedback, and apply training independently after qualification
• Clear verbal and written communication skills, including timely escalation of questions and unexpected observations, and the ability to organize work, manage multiple priorities, and perform effectively in a team-based graveyard-shift environment
• Reliability, adaptability, and willingness to support changing laboratory priorities and scheduled testing needs, including the regular graveyard schedule of 12:00 a.m. to 8:30 a.m. and occasional additional coverage, including weekends or holidays, when required by laboratory operations and consistent with applicable policies

Preferred Qualifications

• Prior experience with one or more relevant analytical techniques such as ELISA or other plate-based assays, spectrophotometry, automated liquid handling, gel electrophoresis, or wet-chemistry methods
• Familiarity with cGMP, data-integrity principles, LIMS, SAP, or other electronic laboratory systems gained through previous work experience, internships, cooperative education, or advanced laboratory coursework
• Demonstrated experience in a regulated laboratory, biotechnology, pharmaceutical, or manufacturing quality-control environment, particularly supporting potency or other biologic assays