Johnson & Johnson Innovative Medicine Research & Development is recruiting for a Specialist QA Preclinical Auditor position to be located at Spring House, PA or Horsham, PA!
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/. (https://www.jnj.com/)
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Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. Johnson & Johnson's culture is interconnected by the shared values of Our Credo. It's a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.
Johnson & Johnson has an exciting opportunity for a motivated preclinical auditor with experience in Preclinical Quality Assurance! Our Specialist QA Preclinical Auditor is responsible for applying the Health Authority regulations and guidelines, Good Practices and internal company standards to help the company achieve two major objectives in support of the J&J Credo: Meet and exceed the expectations of our customers; and achieve and maintain compliance with regulatory expectations. To support business objectives, a successful Specialist Preclinical Auditor will have orientation to the big picture and attention to detail. The Preclinical Domain spans GLP, GCLP, Discovery/non-GLP work. Are you interested in joining a team that is developing the next generation of innovative medicine that serve our surgeons and patients? Apply today!
Key Responsibilities:
- Leads the planning, conduct and reporting of R&D Quality preclinical routine and non-routine audits of experimental phase, data/report, internal facility and process audits. As well as external audits to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
- Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
- Participates in regulatory inspections in supporting roles.
- May assist in preparation and delivery of training materials.
- Completes training requirements in a timely manner to ensure inspection readiness at all times.
- Participate in projects as assigned by supervisor and interacts with key business partners as appropriate.
- Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.
- Provides consultation to business partners on routine tasks with occasional supervision. Cooperates with business partners when contacted for compliance inquiries and seeks advice on non-routine and more complex issues to ensure a departmental unified position.
Qualifications
Education:
- A minimum of a Bachelor's degree is required, preferably in a scientific or technical field.
Experience and Skills:
Required:
- A minimum of 2 years of experience working in Quality & Compliance, Preclinical Operations, and/or related R&D area.
- Experience working in Pharmaceutical industry or contract research laboratory.
- Experience auditing or working in an analytical laboratory (Bioanalysis-large molecule, small molecule, gene therapy, Immunogenicity, new modalities).
- Knowledge of the pharmaceutical drug development process, applicable regulations, R&D practices, and scientific and quality terminology.
- Broad knowledge of management of standard operating procedures, good documentation practices, and records management.
- Ability to be agile and plan and prioritize work in an efficient manner and work well under time constraints.
- Have excellent communication, organization, investigation, and negotiation skills, and be diplomatic.
Preferred:
- Familiarity with new and emerging technologies and analytics, and ability to find opportunities where creative capabilities may be applied within QA audit processes.
- Experience conducting Quality Assurance audits.
- Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, etc.).
- Inspection support experience (FDA, EMA and other inspectorates).
- Experience in a R&D/Pre-Clinical QA, analytical, R&D laboratory, Laboratory that conducts analysis of GCP samples.
- Broad based technical knowledge and skills in diverse areas of business (ex: R&D, Operations, QA, laboratories, etc.)
- Experience working in or providing quality assurance support of a regulated bioanalytical/R&D laboratory.
- Ability to interpret global regulatory standards.
Other:
- This position is expected to have up to 25% travel
- Certification (e.g. Society of Quality Assurance, Registered Quality Professional - GLP - RQAP-GLP).
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.