Analyst I QC Potency - Berkeley, CA

Analyst I QC Potency - Berkeley, CA Berkeley, CA Job Details $64,720 - $97,080 a year 1 day ago Benefits Health insurance Dental insurance Paid time off Vision insurance Qualifications Stability testing Electrophoresis Report writing Immunoassays Laboratory equipment maintenance Analytical chemistry Procedural guides Immunological laboratory techniques 5 years Bachelor of Science SAP Regulatory compliance Compliance audits & assessments Process improvement Equipment troubleshooting Laboratory information management systems Corrective and preventive actions (CAPA) GMP Technical report writing Wet chemistry Change management Project management Laboratory regulatory affairs Hematology Laboratory quality control Data entry Organizational skills Cleaning VBA Quality standards in production Root cause analysis Instrument maintenance Bachelor of Arts Communication skills Spectroscopic techniques Entry level Full Job Description At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Analyst I QC Potency - Berkeley, CA Analyst I QC Potency As an Analyst I QC Potency, you will play a crucial role in performing and ensuring the completion of analytical laboratory testing, including intermediates, final container, stability, and special testing. You will contribute to department improvement projects, identify root causes for investigations, and enhance laboratory test methods. Additionally, you will perform laboratory discrepancy investigations and support the implementation of corrective and preventative actions.

YOUR TASKS AND RESPONSIBILITIES

Perform analytical testing to support the release, stability, and in-process testing of raw materials, samples, or final products, and support the release of materials for production or products for commercial use; Accurately follow relevant SOPs, perform all activities in accordance with cGMP requirements, report abnormalities, and initiate and complete laboratory discrepancy events on time; Legibly document test results to ensure completeness and accuracy per cGMPs, keep accurate documentation, and track records. Compile, enter, and review data into LIMS or other databases/Excel sheets, evaluate data, interpret trends, and write Quality Control technical reports; Demonstrate knowledge of operating, maintenance, and troubleshooting skills for analytical instruments, as well as quality and regulatory requirements pertinent to quality control labs. Perform laboratory cleaning activities; Contribute toward the development, revision, application, maintenance, validation, and review of quality systems, drafting SOPs, and methods for processing and/or ensuring quality in raw materials, intermediates, or finished products; Perform Discrepancy Management investigations, create drafts of laboratory investigation reports, and support department improvement projects related to release goals, the identification of root cause for investigations, and the improvement of laboratory test methods. Support the implementation of corrective and preventative actions, including change and project management; Perform assay training, manage multiple tasks concurrently and effectively, and perform non-routine laboratory tasks; Assist with addressing questions during regulatory compliance audits and support inspection-related needs as required.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

BS/BA degree in a scientific discipline or equivalent education/training; Minimum of 5 years of experience performing relevant activities, including working in a cGMP compliant environment; Experience with a cGMP and global regulatory compliance organization; Experience with hematology-related testing methods or FVIII potency testing; Experience with automated instrumentation (e.g., Hamilton or ACL); Strong computer and communication skills; Experience with equipment and analytical method validation laboratory execution; Strong technical writing skills for reports and SOPs.

Preferred Qualifications:

Experience with Wet-Chemical techniques, Elisa assays, Gel Electrophoresis, Capillary Electrophoresis, Spectroscopy; Familiarity with Bayer products and manufacturing processes; Hamilton (Venus) script writing, LIMS development, or VBA programming; Familiarity with LIMS and SAP systems.

Shift hours:

12:00 AM - 8:30 AM, Monday through Friday. Candidates must be flexible to support business needs , including occasional weekend work when required to meet operational timelines. Employees can expect to be paid a salary between $64,720.00 to $97,080.00. 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 3/23/26. #LI-US #

LI-AMS 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:

862643

Contact Us Email: