QC Microbiology Analyst

Janssen Biotech , Inc. is part of the Janssen Pharmaceutical Companies is recruiting for an Associate Analyst in their Microbiology Laboratory in Malvern, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen BioPharma, Inc. is part of the Janssen Pharmaceutical Companies.

Do you want to be a part of the change?

The QC Associate Analyst, Microbiology position supports the Quality Control Microbiology laboratories and conducts biochemical, microbiological, and/or general chemical testing of raw materials, in-process or final product samples submitted to the QC laboratories. The position requires analytical testing to be completed in compliance with all applicable procedures, standards and GMP regulations. This position requires high attention to detail, organizational leadership, interpersonal skills, a quality mindset, critical thinking, and technical writing skills. This position will work in a team environment.

Responsibilities:

Perform analytical testing in compliance with applicable GMP regulations while maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations. Conduct biochemical, microbiological, and/or general chemical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.

• Perform peer review of laboratory data
  
• Use electronic systems (LIMS, MES, LES, Empower, Trackwise, etc.) for execution and documentation of testing
  
• Maintain Laboratory Housekeeping including sample management, reagent prep, instrument standardization/calibration
  
• Complete Document Revisions
  
• Maintain individual training completion in a compliant state and train new laboratory personnel
  
• Participate in continuous improvement
  
• Complete CAPAs when required for the Quality Control organization
  
• Maintain Laboratory in audit ready state and participate in internal and Health Authority inspections
  
• Provide input to functional laboratory meetings
  

• Minimum of a Bachelor's degree in a life science is required
  
• Minimum of 1 year of proven experience is preferred
  
• Experience with basic laboratory skills and some experience/knowledge of analytical methodologies (bioburden, endotoxin, environmental monitoring, etc.)
  
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems is required
  
• Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing is preferred
  
• Basic knowledge of Johnson & Johnson Quality and Compliance standards is preferred
  
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols is required
  
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required
  
• This position is located in Malvern, PA
  
• Able to work Monday-Friday 8AM-4PM is required
  

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.