J&J Family of Companies QUALITY SYSTEM AUDITOR II in Juarez, Mexico
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Position’s Title: QUALITY SYSTEM AUDITOR II
You will be responsible for:
SECTION 1: JOB SUMMARY* Conducts audits -planned and not planned- to verify the compliance with the government regulations and applicable standards, along with the company policies and procedures. Provides support during the audit external audit readiness and execution. Prepares the required metrics per the Quality Management System and to the actions generated as part of the internal and external audits.
SECTION 2: DUTIES & RESPONSIBILITIES* Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: • Assures that Quality System Audits comply with QSR/GMP and ISO requirements and other applicable regulations to the company. • Conducts internal audits of the Quality System in order to verify the compliance with the government regulations and applicable standards along with the company policies and procedures. Conducts audits of good laboratory practices (GLP) as required. • Provides guidance or advice regarding the compliance with applicable standards and regulations • Conducts re-audits to deficient aspects and to implemented corrective/preventive actions as needed and required. • Assigns classifications to internal audit observations and document the audit results in written reports that are distributed and reviewed by the appropriate management. • Monitors the effectiveness of the corrective actions documented on the observation responses. • May be lead auditor of auditors’ team, technical experts, trainee auditors, and/or volunteer auditors. • Reviews appropriateness of responses to audit observations, also, acts as consultant of other areas that are not audited by him/her, providing advice on audit observations response. • Maintains the audit reports files, re-audits files and the responses to the audits performed. • Conducts audits to other J&J sites as required per the management. • Prepares, reviews and assures to meet metrics related to Compliance and communicate them to the site management and Franchise. Prepares information for the Management Review meetings and/or other forums as required (QSMR, DRB, QPR, Quality Metrics). • Keeps updated on government regulations and applicable standards changes through publications, participation in seminaries or collaboration with organizations. o Responsible for communicating business related issues or opportunities to next management level. o 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 o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed.
SECTION 3: EXPERIENCE AND EDUCATION* • Bachelor’s Degree (BS) in Engineering or Business. • Typically requires 2 years of experience (desirable) and/or training in related areas. • Experience working in FDA regulated environment (desirable)
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* • Effective communication skills –verbal and written- (English and Spanish) • Analytical skills to interpret scientific and technical publications and legal documents • Skills for selecting, managing, and leading a team during an audit. • Skills to present information in an effective way to the upper management, public groups and/or directors. • Skills to work with mathematic concepts for example probability and statistical inferences, geometry fundamentals and trigonometry. • Skills to interpret a variety of instructions presented written, verbal, or graphical (diagrams or programs). • Skills to use the personal computer and associate systems (software). • Skills to effectively interact with government and independent auditors. • Skills and knowledge in methods and techniques related to quality, including auditing principles and techniques, quality terminology, quality administration principles and their applications, along with the quality administration tools and their applications. • Knowledge on problem solving techniques • Lead Auditor Certification (desired)
Primary Location: Cordis de Mexico SA de CV
Reporting to: QUALITY SYSTEMS MANAGER
Cordis de Mexico S.A. de C.V. (8286)
J&J Family of Companies
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