Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Analyst, Quality Control! This position will be located in Malvern, Pennsylvania.

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 Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Are you interested in joining a diverse and dynamic team that is helping improve patient care and drive innovation? Apply today!

The Senior Analyst Quality Control Lab Services, New Product Introduction position supports the overall QC organization and act as QC representative for NPI related change control

• Communicate and Coordinate NPI related testing within QC department
• Act as QC representative on site and core teams for NPI
• Create Bill of Testing(s)
• Review and Approve DPFDs

Manage method qualifications and hold time studies including protocols and reportsThis position requires organizational leadership, interpersonal skills, technological savvy, and technical writing skills. This position will work cross-functionally and will drive improvements within a global organizational framework.

Responsibilities:

• Act as QC representative for equipment and data integrity teams
• Communicate and coordinate analytical equipment updates and downtime within QC department.
• Develop and complete change controls.
• Create business cases and process through the capital planning process.
• Implement CAPAs when required for the Quality Control organization.
• Maintains individual training completion in a compliant state.
• May be asked to participate in audits.
• Support Health Authority inspections
• Provide input to functional laboratory meetings.
• Make decisions as a QC representative at cross-functional meetings.
• Provide leadership and insight as a member of global project teams.
• Provide QC input as a member of Quality focused projects.

Qualifications

Education: Minimum of a Bachelor’s or equivalent University Degree required

Required:

• Minimum 4 years of relevant experience.
• Skilled in basic and advanced analytical equipment within the functional laboratories.
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems.
• Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements and standards for QC testing.
• Proficient in performing technical writing.
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).

Preferred:

• Ability to independently perform project management functions.
• Proficient in performing technical writing.

Other:

• Requires up to 10 % domestic and international travel.

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.