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Sr. Corporate Compliance Specialist

Location: Northeast

General Summary:

This Position requires excellent skills in communication, time management, in depth analysis, and project completion. Also requires skills in program management, program coordination, and in working with a wide variety of people.

 

Duties and Responsibilities:

Responsible for arranging, conducting, and confirming follow-up actions on Corporate Compliance Audits.

Plan and conduct requested audits of specific products, processes, or areas. To include investigation, evaluation, and confirmation of follow-up.

Responsible for working with QA management/teams on validations, protocol and process reviews, and implementation of requirements in compliance programs.

Plan and conduct scheduled corporate audits to assess compliance with FDA, ISO, MDD, and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. Occasionally, this may require scheduling and coordination of audits conducted by audit personnel at a divisional level.

Participate in planning, coordination, and implementation of corporate audit policies. To include review of updated QSR regulations and current FDA and non-US requirements (ISO) and incorporation into internal programs where appropriate.

Review, understand, and implement changes related to ISO/QSR changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs. Participation with Corporate and divisional QA on policy/procedure/guideline development. Includes generation, review, and implementation of these documents.

 

Requirements:

Bachelor’s degree or equivalent based on prior work experience.

Training in audit techniques.

Knowledge of human anatomy and physiology desired.

Certification by ASQC, or equivalent, desired.

Comprehensive working knowledge of FDA regulations and guidelines (QSR, 510(k), PMA, IDE requirements) or comparable audit requirements and guidelines.

A minimum of five years experience of Compliance Auditing.