STAFF QUALITY SYSTEMS AUDITOR
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**COMPANY**
**JOB RESUME**
Conducts audits— planned and unplanned — to verify compliance with government regulations and
applicable standards, in addition to company policies and procedures. Give guidance or advice to the
organization as it relates to compliance, when required.
**RESPONSIBILITIES**
Under general direction and in accordance with all federal, state, and local laws/regulations and
procedures and guidelines of the Johnson & Johnson Corporation, this position:
- It ensures that Quality System Audits comply with the requirements of QSR/GMP and ISO Standards
- Conducts internal audits of the Quality System for the purpose of verifying compliance with
government regulations and applicable standards, in addition to company policies and procedures.
Conducts good laboratory practice (GLP) audits as required.
- Gives guidance or advice as it relates to compliance with applicable standards and regulations.
- Performs re-audits to deficient aspects and to implement corrective and preventive actions as
necessary and required.
- Assigns classifications to internal audit observations and documents audit results in written reports
that can be distributed and reviewed by appropriate management.
- Monitors the effectiveness of corrective actions documented in observation responses.
- You can be the lead auditor of a team of auditors, technical experts, auditors-in-training, and/or
volunteer auditors.
- Reviews ownership of responses to audit observations, also acts as an advisor to other areas that
are not being audited by him/her, giving advice on audit observation responses.
- Maintains audit report files, re-audit files and responses to audits carried out.
- Accompanies external auditors, representatives of government agencies or those required by
management during the execution of an applicable audit.
- Conducts audits at other J&J sites when required by management.
- Complies with and reviews compliance metrics and communicates them to site management and the
Franchise. Prepares information for Management review boards.
- Participates in the formulation of Regulatory Policies and Procedures in compliance with applicable
local, state and federal standards and regulations through the development of Franchise Documents.
- It is kept up to date on government regulations and applicable standard changes through publications,
participation in seminars or by collaboration with organizations.
- Is responsible for communicating business-related matters or opportunities to the next managerial
level
- For those who supervise or manage personnel, they are responsible for ensuring that subordinates
follow all of the Company's guidelines related to Health, Safety and Environment practices and that
all necessary resources to do so are available and in good condition, if applicable.
- Is responsible for ensuring personal and Company compliance with all Federal, State and Local
company regulations, policies and procedures
- Performs other assigned tasks as needed
**Qualifications**:
**QUALIFICATIONS AND REQUIREMENTS**
- Bachelor's degree in Engineering or related areas (desirable).
- It usually requires 5 years of experience and/or training in related areas.
- Master's degree of preference.
- Experience working in an FDA-regulated environment (desirable) - 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.
- Ability to respond to questions or complaints from clients, regulatory agencies or members of the
business community.
- 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
- Knowledge in problem-solving techniques.
- CQA certification prefe