QC Potency Analyst I - Berkeley, CA

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QC Potency Analyst I - Berkeley, CA

The QC Potency Analyst I plays a pivotal role in ensuring the potency, quality, and reliability of biologic products through chemical and physical analyses performed in a GMP-regulated production site laboratory; the role encompasses product release, in-process control, stability, and special testing, as well as the maintenance and calibration of analytical equipment, administration of samples in SAP/LIMS, and root cause analysis of nonconformities to support robust and compliant operations;

The QC Potency Analyst I further supports GMP activities by contributing to computer system validation, method validation, raw data control and archiving, and the creation and maintenance of GMP documents and regulations, while performing routine analytical testing and related activities to deliver reliable test results during graveyard-shift operations; as part of the local Quality Control Potency team at the Berkeley site, the role collaborates closely with internal laboratory groups, Quality Assurance, Manufacturing, Sample Management, Stability, and technical support functions to ensure continuous, inspection-ready support for the manufacture of high-quality medicines.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, QC Potency Analyst I, are to:

• 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

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.

Employees can expect to be paid a salary between $66,560.00 - $99,840.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.

This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 10-26-26.

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YOUR APPLICATION
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
To all recruitment agencies: Bayer does not accept unsolicited third party resumes.


Bayer is an Equal Opportunity Employer/Disabled/Veterans


Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders. Bayer is an E-Verify Employer. Location: United States : California : Berkeley Division: Pharmaceuticals Reference Code: 892860 Contact Us Email: View email address on hirelifescience.com