Product Quality Specialist

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Quality

Quality Assurance

Professional

Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

We are searching for the best talent for a Product Quality Specialist to be based in Raritan, NJ or Titusville, NJ.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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• Has end-to-end accountability for the stability management and oversight from late stage development through full commercial lifecycle for a portfolio of products.
• Responsible for product quality related activities with a specific expertise in stability.
• Supporting the work of PQI/PQO/PQL and actively contributing to overall smooth functioning of the Stability CoE
• Be expert in specific areas of stability management
• Operate independent in the PQS role with minimal support
• Support departmental goals and activities
• PQS for Product families that are highly complex or L&G of high value requiring interactions with multiple functions and teams.
• Identify opportunities for improvement
• Mentor less seasoned members of CoE
• Participate in cross-functional meetings as needed
• Support stability related escalations as needed
• Support regulatory filings with stability information/data.
• Responsible for stability Protocols/reports
• Stability SME for assigned product, manage temp excursions, CC etc.

• 6-8 years of industry experience
• Education Bachelor’s Degree
• Ability to work with others in a team environment
• Ability to manage individual assignments with minimal guidance
• Ability to read and interpret documents such as SOPs, work instructions, protocols
• Clear knowledge of stability related regs
• Proficient with using Microsoft office applications and web-based collaborative applications

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-) or contact AskGS to be directed to your accommodation…