Method Validation - Quality Control Specialist

 

Bayer Healthcare maintains a commitment to be one of the premier healthcare companies in the world.  Berkeley, California is the global headquarters for the Hematology/Cardiology business unit of Bayer Healthcare Pharmaceuticals, a division of the 9.4 billion Euro Bayer Healthcare AG.  Berkeley is also home to almost all of the division’s biotechnology operations.  With a focus on biopharmaceutical discovery, development, manufacturing, and commercialization, we believe our ability to advance improvements and innovations in patient care will be greatly enhanced by our fully integrated capabilities.

 

We are currently looking to fill the role of Method Validation – Quality Control Specialist. In this position as a Method Validation Specialist, you will develop and validate Chemistry/Biochemistry QC method.  Perform method validation and revalidation studies.  Support or perform method development activities as needed.  Schedule/lead the project by working closely with QC lab management, quality approvers.  Prepare protocols, execute protocols, analyze data, and finalize validation package.  Maintain GMP records of all validation activities.  Work collaboratively in a team environment to accomplish QC Department goals.

 

 

Position Minimum Requirements: Must have at least 2+ years of experience of Method Validation (2-4 year PhD, 4-6 years MS Degree,  6-8 years BS/BA) or related experience.  Must be familiar with SOP revision, preparation of validation summaries for regulatory submissions, and validation master plan.  Must be familiar with method transfer, cGMP and ICH guidelines.  Requires effective verbal and written communication skills.  Required Education: BS or BA Degree in Chemistry, Biochemistry, or Life Sciences degree required.

 

Preferences:  Certifications in Method Validation

 

Bayer Benefits

? Medical/Dental/Vision

? 9 company paid holidays, 3 annual “floating holidays”

? Employee Share Purchase Program

? 401(k) – Bayer matches first 6% of your contributions!

? 100% tuition reimbursement on relevant coursework/degrees

 

 

 

To be considered for this position, please e-mail your resume ASAP to marc.duro.b@bayer.com . 

Please be sure to reference "BK-3815" in the subject line.

 

 

 

Bayer is an Equal Opportunity Employer.