At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world 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 MedTech, 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. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

We are currently seeking a highly qualified individual to join our team as a QC Analyst (Analytical Instrument and Lab Systems) at our new Large Molecule Drug Substance Manufacturing facility in Wilson North Carolina (BioNC). In this key role, you will be responsible for laboratory equipment lifecycle management and CSV support, among others.

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.

Learn more at https://www.jnj.com/innovative-medicine

Essential Job Duties and Responsibilities:

• Participate in the qualification of analytical equipment for related testing functions, for example, IQ/OQ/PQ of HPLC, Spectrophotometry, Endotoxin, Cell Culture and Total Organic Carbon equipment.
• Author SOP’s, Work Instructions and protocols.
• Responsible for the quality control laboratory equipment lifecycle management and CSV support.
• Participate in activities to introduce technologies and computer base applications to a new site, for example eLIMS/iLABS, SDMS, Empower and SoftMax Pro, to improve laboratory efficiency and promote a culture of Innovation.
• Interact with the QC Global organization for the different center of excellence for equipment and information technologies.
• The resolution of unexpected complex compliance or lab instrument and system issues as they arise

Qualifications:

• Bachelor’s Degree in Chemistry, Biochemistry, Micro or science related field with 4+ years related experience in biopharmaceutical or pharmaceutical industry. And/or an equivalent combination of education and experience.
• Working knowledge of regulatory requirements, policies and guidelines. Experience with Quality Control document reviews and regulatory inspection processes.
• Working knowledge of laboratory systems.
• Strong technical knowledge in and experience with QC analytical equipment is required.
• Knowledge of cGMP regulations and FDA/EU guidance is required.

Other Requirements:

• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
• Proven ability to manage multiple priorities and work independently with minimal supervision.
• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
• The ability to work in a team environment and interact with all levels of the organization.

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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.