Johnson & Johnson Careers
Staff Auditor – External Manufacturer’s and Supplier Audit
Requisition ID: 1805641211W
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Summary of responsibilities:
Performs planned and unplanned Supplier or External Manufacturer (EM) audits to verify compliance to applicable government regulations, standards and to company policies and procedures. Provides supplier or EM compliance expertise to the organization as required.
Essential Duties and Responsibilities (Other duties may be assigned):
• Assures that the supplier or EM quality system audit function complies with QSR/GMP, ISO and other regulatory requirements.
• Performs audits of suppliers or EMs for compliance to applicable government regulations, material specifications, to international standards and to company policies and procedures.
• Ensures audit reports are issued within the prescribed time frame.
• Performs supplier or EM re audits of deficient matters and corrective actions, as needed and required.
• Assigns classifications and documents supplier or EM audit results in written audit reports that are distributed and reviewed by appropriate management.
• Monitors the effectiveness of supplier or EM corrective action responses.
• Can serve as lead auditor, leading a team of auditors, technical experts, auditors-in-training and/or volunteer auditors.
• Maintains files containing reports of supplier or EM audits, re audits and corrective action responses.
• Provides direction and guidance to auditors in training and/or volunteer auditors.
• Collects and reviews supplier or EM audit metrics and communicates to site and worldwide management. Generates data for management reviews.
• Assists in formulating supplier or EM procedures to be followed by the auditing group.
• Maintains abreast of regulatory changes through industry publications, seminars, participation in trade organizations, and government meetings.
• Responsible for following all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Education and/or Experience:
- BS in a related science or engineering field of study; and 7 or more years of related experience and/or training; or MS with 5 or more years; or Ph.D. with 3 or more years; or equivalent combination of education and experience.
- Proven ability to conduct and manage audits required.
- Computer Systems Validation experience preferred.
- Knowledge dealing with the Food & Drug Administration.
- Knowledge and skills in quality-related methods and techniques including auditing principles and techniques, quality terminology, quality management principles and their applications and quality management tools and their applications.
Other Skills and Abilities:
- Good written and oral English communication skills. Ability to read, analyze and interpret scientific and technical journals, financial reports, and legal documents. Knowledge understanding in FDA CFR Part 820, Part 11, Part 610 & 611, Directive 93/42/EEC-Medical Devices, ICH including Q7 and ISO 130485 regulations is required.
- Ability to select, manage and direct a team during an audit.
- Ability to respond to common inquiries, regulatory agencies, or members of the business community.
- Strong statistical skills and manufacturing process understanding.
- Ability to lead a team through a root cause analysis problem.
- Ability to effectively present information to top management, public groups, and/or boards of directors.
- High tolerance for ambiguity in a complex environment. Makes the complex clear and easily understood by others.
- Ability to stand firm while being open to new approaches.
- Ability to build partnerships both internally and externally.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to use PC's and associated Microsoft software.
- Ability to effectively interface with governmental and independent auditors.
- Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and trainings are preferred.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and stand for long periods of time. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to fumes or airborne particles and risk of electrical shock.
The position will require approximately 60% travel both domestically and internationally.
Comments: This position description is an outline of the major recurring responsibilities of the job. It is not intended to be all inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.
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