Quality & Audit Job Description

Quality & Audit Job Description

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Quality & audit provides expertise and guidance in interpreting governmental regulations, regulatory agency guidelines, and internal policies to ensure compliance.

Quality & Audit Duties & Responsibilities

To write an effective quality & audit job description, begin by listing detailed duties, responsibilities and expectations. We have included quality & audit job description templates that you can modify and use.

Sample responsibilities for this position include:

Lead debrief meetings with Lead Auditors and Senior Managers and obtain buy-in of QA findings
Share industry best practice, common pitfalls with teams in the region and support global messaging
Assist Quality Assurance Director in review of completed risk assessments, Quarterly Refresh as part of Quarterly Business Monitoring and auditable entities
Lead pro-active “hot reviews”, audit report reviews, Internal Audit location reviews (site reviews), an efficient and effective scorecard evaluation and reporting mechanism, a continuous improvement program and other solutions to drive a best in class quality assurance function for a leading global financial services group
Conducts various first and second residential mortgage loan audits of underwriting and processing functions
Develop and deliver an integrated audit programme that fulfils all regulatory and business requirements
Manage audit action plans to ensure they are fully completed by the business in a timely manner, including those resulting from third party assessments
Provide strategic advice and expert guidance for the business, including directors and senior managers throughout the business, on all matters related to the integrated audit programme and third party assessments
Develop internal relationships across key areas of the business in order to support business change in response to needs identified by audit and monitoring activities, and to champion best practice across the business
Liaise with external agencies, including Ofqual and SQA, as required in connection with the role

Quality & Audit Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality & Audit

List any licenses or certifications required by the position: CIA, CPA, ISO9001, CISA, ISO27001, ISO22301, ISO, ASQ, CRC, CAMS

Education for Quality & Audit

Typically a job would require a certain level of education.

Employers hiring for the quality & audit job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and High School Degree in Business, Engineering, Accounting, Finance, Science, Education, Management, Technical, Business/Administration, Guidance

Skills for Quality & Audit

Desired skills for quality & audit include:

Medicaid
MS Office applications
Agency guidelines and Caliber overlays
Applicable laws and regulations
HIPAA and pharmacy claims processing
Medicare and TDI regulatory standards
Agency
Commercial and Medicare products
Excel and PowerPoint
FHA/VA/USDA guidelines

Desired experience for quality & audit includes:

Managing department procedures and documentation relating to audit
Developing and implementing a comprehensive set of work measures and performance metrics that facilitate fact based decision making
Liaise with, and provide expert guidance to, the customer services complaints team and the legal team in the resolution of serious complaints
Provide clear, timely and authoritative reporting to agreed formats and as appropriate to different audiences, internal and external, and ensure that all required reporting is completed within agreed timeframes and to the highest quality
Line manage, train, supervise and develop members of the team as required and work with senior managers within the division to encourage the development of members of staff, all in accordance with good practice and the people manager policy
Contribute to timely and effective Management Reviews to support our business certifications, particularly in relation to the audit function

Quality & Audit Examples

1

Quality & Audit Job Description

Job Description Example
Our innovative and growing company is hiring for a quality & audit. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality & audit
  • Undertake the lead or support of specific projects as directed by line management
  • Participate in cross-departmental monitoring, audit and other project activity
  • The Audit and Quality Specialist will also support the broader work of Business Improvement and Regulation by working flexibly across the various functions of the division, including investigations into cases of appeal, malpractice, maladministration and breaches of security, regulatory monitoring, business continuity and data protection, when required to do so
  • Of the process analysis and resolution steps
  • Working with the Quality Management peer group and CS Management Team, identify common themes and performance trends, and make recommendations to address weaknesses
  • Assisting with the provision of appropriate management information to the Head of Audit and Quality, the Director of Business Improvement and Regulation and other senior management as required
  • The Audit and Quality Specialist will also support the broader work of Business Improvement and Regulation by working flexibly across the various functions of the division, including investigations into cases of appeal, malpractice, maladministration and breaches of security, regulatory monitoring and business continuity, when required to do so
  • The Senior Audit and Quality Specialist will also support the broader work of Business Improvement and Regulation by working across the various functions of the division, including investigations into cases of appeal, malpractice, maladministration and breaches of security, regulatory monitoring and business continuity when required
  • Designs And Manages The Creation Of Policies And The Implementation Of The Strategies To
  • An understanding of the technical aspects of the areas being audited – understand the process, operational terminology
Qualifications for quality & audit
  • Support the Audit and Quality team in ensuring compliance with internal procedures, regulatory requirements and external business standards such as ISO9001 (Quality Management), ISO27001 (Information Security) and ISO22301 (Business Continuity)
  • To monitor and update team logs to ensure that cases and actions are completed within the agreed timescales
  • To provide high quality administrative support to the Head of Audit and Quality, Audit and Quality Manager or Senior Audit and Quality Specialist
  • To support specific projects as required by line management across Business Improvement and Regulation
  • Collate management information for Management Review as required by the Head of Audit and Quality, Audit and Quality Manager and Senior Audit and Quality Specialist or other senior management within Business Improvement and Regulation
  • Two years’ work experience in a Quality inspection/auditing role in pharmaceutical ,cosmetics or FMCG environment preferred
2

Quality & Audit Job Description

Job Description Example
Our growing company is looking for a quality & audit. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality & audit
  • Ensure auditing system and database is managed and up to date
  • Supervise, monitor, track and direct day to day operations of staff of up to 10 employees
  • Communicates and presents quality review findings to business leaders
  • Develops & implements quality audit metrics and scorecards to analyze & assess trends identify and prioritize quality issues & control gaps
  • Leads more complex reviews & testing procedures to determine compliance with critical and required controls
  • Manages a team to conduct quality audits for assigned area
  • Evaluates audit responses for adequacy, including root cause, timeliness utilizes knowledge to facilitate appropriate corrective action
  • Verify correct interpretation of coding, contract adjudication, and following of mandated guidelines
  • Advise examiners or editors of needed corrections and of new contract updates
  • Correspond with the IPA Executive Director or designated assistant regarding payment issues and contract issues
Qualifications for quality & audit
  • To monitor and update team logs to ensure that audits and actions are completed within the agreed timescales
  • To provide high quality administrative support to the Head of Audit and Quality or Senior Audit and Quality Specialist
  • To support specific projects as required by the Head of Audit and Quality or the Director of Business Improvement and Regulation
  • Collate management information for Management Review as required by the Head of Audit and Quality, Senior Audit and Quality Specialist or other senior management within Business Improvement and Regulation
  • Collate management information for Management Review as required by the Head of Audit and Quality or other senior management within Business Improvement and Regulation
  • Must possess strong communication, project management and leadership skills have the ability to manage multiple projects simultaneously
3

Quality & Audit Job Description

Job Description Example
Our growing company is hiring for a quality & audit. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality & audit
  • Provide global Quality governance via routine audit processes and Due Diligence activities
  • Participate in management and preparation of the inspections as required to support business development and other GQA activities
  • Provide Quality support and advice to support business development projects
  • Provide leadership in driving continuous improvement of inspection readiness activities across the global network
  • Deliver timely outcomes in execution of compliance improvement projects as assigned
  • Participate/ support Global Quality initiatives in alignment with the vision, annual goals and assistance as assigned
  • Support Due Diligence activities worldwide in conjunction with Head of Global Quality Audit Due Diligence
  • Participate in internal and external audits in accordance with the approved GQA audit schedule as required
  • Ensure all audits and inspections are executed in accordance with company procedures and reported on within agreed format and timelines
  • Promptly escalate and report all critical audit findings to the Global Quality Audit Region Head in accordance with Global Audit policies and procedures
Qualifications for quality & audit
  • Coordinate, host and ensure proper follow up of external audits, as assigned (e.g., Customer Audits and ISO audits)
  • Administrative activities related to the management of the internal audit function
  • Coordinate and review the work of team members reporting to this position
  • Five years of experience conducting audits in the medical device industry
  • Expertise in FDA 21CFR Part 820(QSR), ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations, J-PAL (Japanese), MDD (European) requirements
  • Apply effective time management, critical thinking, problem solving and collaborative approaches to improving training program and corrective action plans
4

Quality & Audit Job Description

Job Description Example
Our innovative and growing company is looking for a quality & audit. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality & audit
  • Ensure personal training is completed on time for all global quality policies, standards and procedures
  • Participate in inspection preparation activities at sites prior to significant inspections as required, including inspector profiling and 483 and EIR trend review
  • Be a role model for Takeda-ism and provide positive representation of Takeda when dealing with external partners
  • Engage and support appropriate projects such as Inspector Reviews, FDA 483 reviews as required
  • Partner with Quality functions such as Global Compliance to understand points of emphasis during upcoming audits such as Quality Systems performance and alignment on Quality Culture
  • Ability to clearly communicate QC findings and provide coaching to associates
  • This position is required to assess and provide a clear vision of compliance across the SM Global Sites
  • Develop and deploy the shared audit program
  • Responsible to develop annual risk-based audit schedule across all Medical division sites
  • Ensure SMRAC audits are performed in accordance with global SMRAC Audit program to ensure that all Sites and global processes receive SMRAC Audits appropriate to assessed compliance risk, business needs and local needs
Qualifications for quality & audit
  • GMP/ GDP Regulations ANSM, USFDA, EU, WHO
  • 5 – 10 years’ experience with Global Quality systems conducting audits within a GMP environment
  • Ability to multi-task and function independently as required
  • Extensive knowledge of Canadian GMPs/GCPs FDA and international guidelines and regulations
  • Oversee annual delegated program evaluations, program descriptions, policies & procedures
  • Independent Certifications desired
5

Quality & Audit Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality & audit. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality & audit
  • Perform or aid in the team effort performing due diligence audits of prospective acquisitions
  • Provide appropriate feedback of findings from Audits, highlighting areas for concern to the Director of Government Relations and Compliance
  • Rigorously monitor responses to all Regulatory Audit and Compliance findings to ensure effectiveness of actions and assist in resolutions where requested and appropriate
  • Acts as the first point of contact for escalated issues coming in to his/her work group to provide resolution to internal business partners and external customers
  • Creates and maintains up to date training materials and audit reports as needed
  • Delivers training to team members as needed to meet department objectives
  • Performs audits on various functions for team members by applying expanded knowledge obtained from the role
  • Provides responses and a diverse range of information to team members without supervision
  • Recognizes increasingly complex issues/concerns for assigned area(s) of responsibility, explains effect on the work unit, and suggests process improvements
  • Provide guidance and leadership on all Internal Audit matters product compliance to the facility
Qualifications for quality & audit
  • Experience with FDA and international regulations (pharmaceutical and/or device, , 21 CFR 812, 50, 54, 56, 820, ISO 13485, ISO 14155) and/or experience in Quality System regulations
  • Travel with colleagues and manager as requested
  • Seven+ years of current and/or recent financial statement audit experience within a public accounting firm with demonstrated supervisory experience and SEC issuer inspection experience
  • Ability to read and follow a documented SOP
  • 2+ years experience with billing OR insurance processes
  • Ability to create and modify spreadsheets within MS Excel

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