Regulatory Compliance Specialist II

JOB SUMMARY

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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

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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

• Perf...