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:

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 team as a QC Microbiology Specialist at our new Large Molecule Drug Substance Manufacturing facility in Wilson North Carolina (BioNC). In this key role, you will be responsible for conducting microbiological testing of raw material, in-process, or final product samples submitted to the QC laboratories. This position requires testing to be completed in compliance with all applicable procedures, standards, and GMP regulations.

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.

Essential Job Duties and Responsibilities:

• Responsible for execution of microbiological testing (i.e. bioburden, endotoxin, growth promotion, microbial identification, etc.) within the QC Microbiology laboratory.
• Develops and executes analytical method qualification, validation, and transfer with minimal guidance.
• Performs peer review and/or approval of laboratory data.
• Authors, reviews, or approves related SOPs, WIs, and technical documents.
• Trains and mentors incoming QC Microbiology laboratory personnel.
• Utilizes electronic systems (eLIMS, MES, etc.) for execution and documentation of testing.
• Maintains a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Collaborates with cross-functional teams (Operations, Engineering & Maintenance, MSAT, QA,
• etc) to address quality issues
• Performs statistical analysis, data trending, and reporting.
• Provides input to functional laboratory meetings.
• Provides QC input at cross-functional meetings.
• Supports Health Authority inspections.
• Maintains individual training completion in a compliant state.

Qualifications:

• Bachelor's degree in Microbiology, Biology, Biochemistry or related field is required.
• Minimum six (6) years experience working within the biological and/or pharmaceutical industry in a laboratory setting is required.
• Prior demonstrated success at the QC analyst level, and/or an equivalent combination of education and experience is required.
• Strong knowledge of compendial (USP, EP, JP, etc.) requirements and standards for QC testing.
• Strong working 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, Annex 1, etc.) guidelines in a biological or pharmaceutical manufacturing environment.

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.

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 in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a QC Microbiology Specialist. 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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