Regulatory Auditor

Company Name:
Fisher Scientific
Regulatory Auditor
Job ID: KD20141812-32633
Expertise Quality Assurance
Education Bachelors
Job Type Full-time
Location United States - Pennsylvania - Allentown
Job Level Experienced
Posting date: December 24, 2014
Position Summary:
This position is responsible for scheduling, sending internal notifications, hosting, generating reports, and formulating responses to both regulatory and client audits. The Regulatory Auditor is responsible for arranging the site self inspections and conducts external supplier audits. The Regulatory Auditor will also ensure audits observation commitments are implemented in a timely manner.
Essential Duties and Responsibilities:
Schedule and host regulatory and client audits. Notify Senior Management of audit findings.
Coordinate and finalize responses in audit reports.
Lead periodic planned site self inspection based on criticality and/or annual measure of departmental activities and processes (e.g. QA, Operations, Client Services, IT Supply Chain, HR) to assess compliance to cGMP, SOP's and regulatory requirements.
Must become familiar with all levels of FCS operations.
Trend observations of external and internal audits.
Assist the North America Audit Team in conducting supplier audits in support of Fisher North America and other FCS sites when needed. Prepare audit observations report and/or comments to suppliers and follow-up until closeout.
Maintain an approved Supplier Qualification list.
Maintain awareness of current regulatory requirements and guidance.
Maintain electronic files of inspections and certifications.
Complete requests for Vendor/Supplier Questionnaires.
Apply and maintain regulatory licenses for North America.
Demonstrates and promotes the company vision.
Applies Good Manufacturing Practices in all areas of responsibility.
Basic Minimum Qualifications (BMQ):
Experienced Quality professional with experience in auditing.
Must have 4-7 years audit experience in a regulated industry.
Must have good oral and written communication (business writing) skills.
Education/ Experience
Bachelor degree (B.A./B.S.) required.
4 years + experience in the Pharmaceutical/Medical Device industry.
Experience with Management, Six Sigma, Lean, Practical Process Improvement, etc.
Experience in CFR, cGMP, QSR, ISO, ICH and Health Canada standards/regulations is preferred.
Certificates and/ or Licenses (BMQ):
Active/current CQA certificate through ASQ or a comparable auditing association/body is preferred.
Must have a valid driver's license and active passport for local, domestic and international travel.
Supervisory Responsibility:
This position has no direct supervisory responsibility.
Internal and External Contacts:
Direct contact with all internal departments as well as external customer representatives as required. (QA, Operations, Client Services, Supply Chain, Finance, Sales IT and other groups)
Ability and/or Skills:
Maintain a professional image while hosting or performing audits.
Excellent knowledge of cGMP requirements including Good Documentation Practices.
Ability to prioritize requirements and audit observations.
Must be able to wear cleanroom garb and PPE at the vendor/supplier sites during audits as required.
Excellent verbal and written communication.
Good problem solving skills.
Strong ability to drive tasks/projects to closure in a timely fashion.
Ability to respond to observations with a global outlook and objective evidence to prove actions are completed.
Have superior investigative and Root Cause Analysis skills.
Experience preferred in hosting a regulatory audit (FDA, Health Canada, MHRA or etc.)
Possess a pro-active approach to issues with a drive to follow through to closure.
Demonstrate flexibility in approaches to resolve compliance issues.
Must be willing to travel to sites located throughout the USA and international.
Proficient in Microsoft Office applications and other support databases inclusive of auditing template programs as identified.
Add'l preferences:
Work Schedule:
Monday - Friday 8 AM-5 PM; Additional hours as necessary
Other Factors:
May be required to lift 10 - 20 pounds
This position is not approved for relocation.
This position description is written as a guideline to inform Thermo Fisher Scientific Employees of what is generally expected of them at each job level. The description is not intended to be all encompassing or limiting in any manner; rather, it is hoped it will add understanding and better reflect the work performed at all levels of employment within Thermo Fisher Scientific. Duties and responsibilities other than those listed may be included as needed within the work group or the company as a whole.
The above information is for exclusive use within Thermo Fisher Scientific and may not be used or duplicated by others without written consent.

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