Quality Control Analyst RM/API

Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for an QC Analyst RM/API! This position will be located 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 Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!

The QC (Quality Control) Analyst RM/API conducts general Chemistry testing of raw materials, in-process, or final product samples submitted to the QC Chemistry Laboratory. The position requires time management and testing to be completed in compliance with all applicable procedures, standards, and GMP regulations. Testing includes but not limited to pH, Conductivity, Osmolality, FTIR, Compendial testing, etc.

Responsibilities:

• Complete chemistry testing of raw materials, in-process, or final product samples in timely manner
• Complete testing includes but not limited to pH, conductivity, FTIR
• Maintain Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.
• Update SOP, TMD, Protocol/Validation Reports
• Applying statistical concepts to laboratory data
• Experience developing and setting long-term objectives
• Support of 24 hr manufacturing schedule
• Support of New Product Initiatives (NPI)
• Support qualifications for new products/materials

Qualifications

Education:

• Minimum of a Bachelor’s or equivalent degree in Biology, Biochemistry, Microbiology, Chemistry or related field is required

Required:

• Minimum two (2) years of experience testing includes but not limited to pH, Conductivity, Osmolality, FTIR, Compendial testing, etc.
• Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry
• Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)
• Experience with one or more of the analytical technologies used in the chemistry based assays
• Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols
• Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)

Preferred:

• Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Ability to complete equipment and software qualification protocols
• Experience developing and setting long-term objectives
• Experience working in Biosafety Level lab
• Experience, training, or certification in Lean, Six Sigma, or Process Excellence tools & methodologies
• Knowledge of EU/FDA guidance

Other:

• Requires ability and flexibility to accommodate unplanned overtime (including nights and weekends) on little to no prior notice outside of Monday-Friday 8:00AM to 4:30PM.
• Requires the physical ability to lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting, and ability to perform visual inspections of materials (color, appearance, particles, etc.) and to document observations during laboratory testing
• The anticipated range for this position is $60,000 to $87,500

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 .