QC Potency Analyst I - Berkeley, CA

Bayer•Berkeley, CA

24d•$66,560 - $99,840•Onsite

About The Position

The QC Potency Analyst I performs chemical and physical analyses in a GMP-regulated production-site laboratory to ensure the potency, quality, and reliability of biologic products. The role supports product release, in-process control, stability, and special testing during graveyard-shift operations. It also involves maintaining and calibrating analytical equipment, administering samples in SAP/LIMS, and supporting investigations into nonconformities. The analyst contributes to GMP activities such as computer-system and method validation, raw-data control and archiving, and the creation and maintenance of GMP documents. Working as part of the Berkeley site's QC Potency team, the role collaborates with internal laboratory groups, Quality Assurance, Manufacturing, Sample Management, Stability, and technical support functions to support compliant, inspection-ready manufacturing of high-quality medicines.

Requirements

Up to two years of laboratory experience in an academic, biotechnology, pharmaceutical, or cGMP environment, or equivalent hands-on laboratory training demonstrating readiness to work 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 laboratory practices, including calculations, solution preparation, pipetting, and safe handling of laboratory materials.
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; ability to work with electronic systems such as LIMS and SAP in alignment with cGMP and data-integrity principles.
Attention to detail and commitment to quality, safety, and data integrity; 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.
Ability to organize work, manage multiple priorities, and work effectively in a team-based graveyard-shift environment.
Reliability, adaptability, and willingness to support changing priorities and scheduled testing needs, including the regular 12:00 a.m. to 8:30 a.m. schedule and occasional additional coverage, including weekends or holidays, when required.

Nice To Haves

Prior experience with 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 work experience, internships, cooperative education, or advanced laboratory coursework.
Experience in a regulated laboratory, biotechnology, pharmaceutical, or manufacturing quality-control environment, particularly supporting potency or other biologic assays.

Responsibilities

Perform routine potency and related analytical testing in accordance with approved methods, specifications, SOPs, and cGMP requirements for in-process, release, stability, and special testing.
Prepare samples, reagents, standards, controls, and equipment; maintain laboratory readiness through cleaning, inventory checks, preparation of supplies, and organization of assigned work areas.
Operate laboratory instruments and automated systems after required training and qualification; perform routine checks, cleaning, and basic troubleshooting.
Document activities and results contemporaneously, accurately, and legibly in controlled records and approved electronic systems, including LIMS or other laboratory databases; review data for completeness and report deviations, atypical observations, instrument issues, and abnormalities.
Initiate or support laboratory discrepancy and investigation records, collect relevant data, and complete documentation within established timelines.
Follow laboratory safety requirements for biological materials, chemicals, sharps, and laboratory waste; uphold quality, safety, and data-integrity standards.
Manage multiple assignments and changing priorities while maintaining data integrity, quality, and schedule commitments; complete training and progressively qualify on QC Potency methods, systems, and processes.
Provide clear shift handoffs and communicate testing status, issues, and follow-up needs to graveyard- and day-shift colleagues.
Participate in continuous-improvement, inspection-readiness, and team activities that enhance QC Potency performance and support site quality goals.