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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 Assurance

Job Category:

Professional

All Job Posting Locations:

Wilson, North Carolina, United States of America

Job Description:

About Innovative Medicine

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

We are currently seeking a highly qualified individual to join our Quality team as a Quality Assurance Specialist , at our new Large Molecule Drug Substance Manufacturing facility in Wilson, North Carolina .

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

We are seeking a talented and passionate professional who thrives in a fast-paced environment and is committed to ensuring the highest standards of quality throughout our organization. If you have a keen eye for detail, exceptional problem-solving skills, and strong understanding of regulatory requirements with a proven track record in quality assurance, this is the perfect opportunity for you to make a lasting impact.

As Quality Assurance Specialist, you will be responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures to ensure compliance with regulatory requirements and industry standards supporting project and commercial stages of the new Site.

Key Responsibilities:

• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the J&J Standards.

• Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.

• Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.

• Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).

• Develops and implements processes, procedures and tools related to the implementation of compliance systems at the site.

• Responsible for execution of Risk Management Program through the identification, assessment, and management of quality risks. Implement appropriate preventive measures and corrective actions to minimize potential quality issues.

• Implement and execute the Notification to Management/Escalation procedures as defined by J&J standards and procedures. Facilitate timely resolution through coordination with relevant department and teams.

• Responsible for development and implementation of Data Integrity Program for the BioNC site in alignment with J&J standards and procedures.

• Responsible for preparation, review and submission of data reported to Health Authorities including BPDRs, Inspection responses and review of Regulatory submission documents.

• Collaborates and contributes to Site Inspection Readiness Activities, including global internal audits and assessments.

• Collaborate with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QC, etc) to address quality issues.

• Provides support to documentation review through evaluation and approval of documentation related to regulatory submissions, standard operating procedures (SOPs), and quality management systems to ensure accuracy and compliance.

Qualifications:

Education

• Bachelor's degree in a scientific, engineering or equivalent discipline is required.

Experience and skills

Required

• Minimum of four (4) years of experience working within the biological and/or pharmaceutical industry in a quality, manufacturing, or compliance role.

• Strong knowledge of relevant regulations and quality management principles, such as Good Manufacturing Practices (GMP), ICH, and ISO standards.

• Understanding and experience in application of global regulatory (FDA, EMA, etc.) guidelines in a biological or pharmaceutical manufacturing environment.

• Experience with regulatory inspections and response to observations.

• Proficiency in risk management methodologies such as FMEA.

Preferred

• 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.

• 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.

• Ability to build and nurture strong and positive relationships.

• The ability to work in a team environment and interact with all levels of the organization.

Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.

If you are passionate about quality, GMP, and compliance in the biotech/pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a QA Specialist, Regulatory Compliance. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment.

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 and 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-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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