External Auditor Job Description
External Auditor Duties & Responsibilities
To write an effective external auditor job description, begin by listing detailed duties, responsibilities and expectations. We have included external auditor job description templates that you can modify and use.
Sample responsibilities for this position include:
External Auditor Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for External Auditor
List any licenses or certifications required by the position: CQA, ASQ, ISO, CPA, CHC, CPMA
Education for External Auditor
Typically a job would require a certain level of education.
Employers hiring for the external auditor job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Education, Accounting, Business, Finance, Auditing, Guidance, Technical, Medical, Oral Communication, Sound
Skills for External Auditor
Desired skills for external auditor include:
Desired experience for external auditor includes:
External Auditor Examples
External Auditor Job Description
- Plan, implement and document internal and external audits
- Assess supplier quality system
- Close out of identified audit findings
- Review and evaluate audit reports
- Support and assist suppliers to improve their quality standards
- Qualifications as approved auditor in aerospace industry desirable (AS9100, AS9001, EASA Part21- Part145)
- Degree in Mechanical Engineering, Production Engineering or Quality Management (or similar)
- Expertise relating to production methods
- Proven track record in relevant field
- Experience in applying measurement and inspection methods
- Experience in auditing of CMOs, Contract packagers, Contract Laboratories and other vendors
- Undergraduate degree in Accounting, Finance, Economics, or comparable major
- Experience working with management to build trust and to support operations
- In possession of relevant professional certification (i.e., CIA, CPA)
- Fluent in English, both in writing and verbal
- Completion of undergraduate core coursework in accounting, business administration, computer science or related field
External Auditor Job Description
- Good understanding of standard MS Office applications
- Driving licence and willingness to travel at an international level
- Assist in the identification, implementation and maintenance of the program/organization’s supplier management policies and procedures
- Perform ongoing supplier compliance monitoring activities
- Work with regulatory experts to ensure the practice/organization maintains appropriate documentation related to supplier management
- Participate in the development, implementation, and compliance monitoring of Business Associate Agreements
- Establish and administer process for receiving, documenting, tracking, investigating and taking action on complaints related to suppliers
- Audit external suppliers that support various Watson Health Offerings
- Independently monitors Area Agencies on Aging (AAAs) & PASSPORT Administrative Agencies (PAAs)
- Conducts routine financial, compliance &/or operational reviews of various state & federal aging programs & ensures compliance with applicable policies, rules & regulations
- Ability to build partnerships both internally and externally
- Ability to use PC's and associated Microsoft software
- Six Sigma, Lean, ISO lead auditor, or ASQ CQA certification and trainings are preferred
- Knowledge and experience in healthcare and/or medical device compliance laws and regulations
- Strong English writing and oral communication skills
- Audit experience and skills
External Auditor Job Description
- Assists in identifying updates to law/rules/regulations as they impact the agency & the monitoring process
- Provides technical assistance to AAAs/PAAs during the monitoring process
- Participates in meetings with agency & representatives of the audited entity to review audit findings & recommendations
- Prepare, coordinate, participate, and administer external regulatory audits and inspections
- Train all inspection support personnel in assigned Site Regulatory Inspection team roles in addition to the inspection support structure and process
- Leads Site Management in formalizing a response, corrective and preventive actions, and related commitments to any external regulatory agency citation/observation/finding
- Perform key compliance projects including gap assessments to ensure compliance with regulatory requirements, including FDA, Health Canada, and other international audits as assigned
- Coordinate, execute, and perform lead audit functions during internal cGMP audits to assure compliance with applicable regulations and international laws and standards, guidelines, and procedures
- Manage and support compliance projects to achieve plant quality objectives and initiatives including benchmarking with other sites and participating on committees/teams that support cGMP compliance programs
- Edit, write, review and approve standard operating procedure change controls
- 5 years of work experience interfacing with and auditing external suppliers or subcontractors in healthcare and /or medical device regulated environments
- 7 years of work experience in a Healthcare or medical device company
- Healthcare industry certifications
- Healthcare industry training
- MBA or Masters in Accounting preferred
- Requires a Bachelor’s in Accounting or a related field
External Auditor Job Description
- Track, maintain, and report Quality Compliance metrics related to External audits and inspections
- Perform supplier qualifications, participate in continuous supplier monitoring activities including, but not limited to issue management and audit
- Critical thinking skills to assist Watson Health teams qualify their internal and external suppliers
- Application of healthcare and life science regulations and standards to supplier qualification, issue management, and auditing
- Continuously improving procedures supporting supplier qualification, management, and auditing
- Maintaining records of supplier qualification and continuous monitoring
- Independently monitor Area Agencies on Aging (AAAs) and PASSPORT Administrative Agencies (PAAs)
- Conduct routine and non-routine financial, compliance and/or operational reviews of various state, federal, and/or Ohio Department of Aging (ODA) policies, rules and regulations
- Assist supervisor with preparing monitoring guidelines and practice aids
- Prepare work papers to document the monitoring of the AAAs/PAAs
- Thorough working knowledge of current Good Manufacturing Practices and domestic/international regulatory requirements (21 CFR 210/211, Current Eudralex Volume, Health Canada)
- Must possess the ability to communicate with all levels of management and lead a cross functional team to perform audits and convey results in an effective manner to site management
- Minimum of five years’ experience with at least two of the years as a lead auditor or serving in a lead auditor capacity in a Pharmaceutical or GxP regulated environment
- Candidate must have inspection interface experience with the FDA
- Works in a variety of areas including office, manufacturing areas, utility areas, and laboratory areas with associated conditions and hazards (including radio frequency)
- Must be able to wear all required area safety equipment and clean room garments for extended periods of time
External Auditor Job Description
- Perform research in support of review and revision of ODA/AAA/PAA policy and procedures
- Assist in identifying updates to law/rules/regulations
- Maintains files containing reports of supplier or EM audits, re audits and corrective action responses
- Assists in formulating supplier or EM procedures to be followed by the auditing group
- Preparation financial statements, audit coordination, statutory filing and tax filing
- Coordinate with other (finance) teams and service provider
- Corporate Income Tax accounting for group purposes
- Support EMEA region on statutory SAP ledger
- Prepare finance updates local board meetings
- Apply LEAN methodologies for process improvements
- Knowledge understanding in FDA CFR Part 820, Part 610, Part 611, Part 11, and ISO 130485 regulations is required
- At least 3 years of work experience interfacing with and auditing external suppliers or subcontractors
- Must be able to walk and stand for extended periods of time while performing audits
- Must be able to work extended periods of time in manufacturing areas where Radio Frequency occurs
- 3-5 years of experience in regulated healthcare or life science industry
- 1-3 years of experience in software development lifecycles