JOB SUMMARY* Conducts audits, planned and unplanned, to verify compliance with government regulations and applicable standards, in addition to company policies and procedures. Provides support during the preparation and execution of external audits. It elaborates the metrics required by the quality system and follows up on the actions generated as part of the internal and external audits. DUTIES & RESPONSIBILITIES* In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: + Ensures that Quality System Audits comply with QSR/GMP requirements, ISO Standards and all regulations that apply to the company. + Conducts internal Quality System audits for the purpose of verifying compliance with applicable government regulations and standards, in addition to company policies and procedures. Conducts Good Laboratory Practice (GLP) audits as required. + Gives guidance or advice regarding compliance with applicable standards and regulations. + Conducts re-audits for deficient aspects and to implement corrective and preventive actions as necessary and required. + Assigns ratings to internal audit observations and documents audit findings in written reports that can be distributed and reviewed by appropriate management. + Monitors the effectiveness of corrective actions documented in observation responses. + May be the lead auditor of a team of auditors, technical experts, auditors-in-training, and/or volunteer auditors. May also be part of the audit team. + Reviews that responses to audit observations are appropriate, also, acts as an advisor to other areas that are not being audited by him/her, giving advice on responses to audit observations. + Maintains audit report files, re-audit files and responses to audits conducted. + Conducts audits at other J&J sites when requested by management. + Prepares, reviews and ensures compliance related metrics; communicates them to site management and Franchise. Prepares information for Management review meetings and/or other forums as required (QSMR, DRB, QPR, Quality Metrics). + Keeps abreast of government regulations and applicable standards changes through publications, participation in seminars or through collaboration with organizations. + Responsible for communicating business related issues or opportunities to next management level + Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. + For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable + Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures + Performs other duties assigned as needed **Qualifications** EXPERIENCE AND EDUCATION* + Bachelor's degree in Engineering or related areas (desirable). + It usually requires 2-3 years of (desirable) experience and/or experience in related areas. + Experience working in an FDA-regulated environment (desirable) REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* + Effective communication skills – oral and written – (English and Spanish). + Analytical skills to interpret scientific and technical publications and legal documents. + Ability to select, manage and lead a team during an audit. + Skills to present information effectively to senior management, public groups and/or directors. + Skills to work with mathematical concepts, such as probability and statistical inferences, fundamentals of geometry and trigonometry. + Skills to interpret a variety of instructions presented in writing, verbally or graphically (diagrams and programs). + Skills for the use of computers and associated systems (software). + Skills to interact with auditors by the government and independents. + Skills and knowledge of methods and techniques related to quality, including audit principles and techniques, quality terminology, quality management principles and their applications, as well as quality management tools and their applications. + Knowledge in problem-solving techniques. + Certification as a lead auditor (desirable).