Job Summary:

• Select goods that will be audited before shipping.
• Open boxes and scan individual units to check if goods are packed complete, if tickets and UPCs read correctly, and goods are packaged correctly.
• Use a computer to check POs, and check goods are packed as per POs specs.
• Work closely with the production floor to check that goods being processed follow customer guidelines.
• Fix shipping labels, and correct any mistakes found during inspection.
• Use a computer to run audit reports.
• Communicate errors found to QC department and Customer Compliance dept., so corrective actions are taken, and originating factories penalized with chargebacks
• Assist Warehouse managers in any other duties required, in their respective areas.

Skills on Resume:

• Goods Selection (Hard Skills)
• Box Inspection (Hard Skills)
• PO Verification (Hard Skills)
• Production Collaboration (Soft Skills)
• Label Correction (Hard Skills)
• Audit Reporting (Hard Skills)
• Error Communication (Soft Skills)
• Warehouse Support (Soft Skills)

Job Summary:

• Schedules and conducts internal and external audits
• Manages and maintains the Internal Audit and Supplier/Vendor qualification program
• Completes and submits Internal and Supplier Audit reports
• Leads internal and vendor GMP, GDP and GLP audits
• Analyze potential risks within specific areas in order to avoid compliance issues
• Performs general risk assessment studies to gauge the possible risk potential of vendors
• Supports readiness of the facility for Regulatory Inspection
• Completes department related Change Controls, CAPAs and Deviations.
• Recommends improvement of controls designed to safeguard the organizations resources and ensure compliance with laws and regulations.
• Conducts special examinations or other duties at the request of the Chief Financial Officer and/or Controller.

Skills on Resume:

• Audit Scheduling (Hard Skills)
• Program Management (Hard Skills)
• Report Submission (Hard Skills)
• GMP Audit Leadership (Hard Skills)
• Risk Analysis (Hard Skills)
• Risk Assessment (Hard Skills)
• Regulatory Readiness (Hard Skills)
• Compliance Improvement (Soft Skills)

Job Summary:

• Assigning team members to quality audits and overseeing their work
• Serves as internal resource for requirements of the quality system and 3rd party/regulatory compliance
• Training employees on quality standards and procedures
• Reviews and revises facility quality documents to ensure consistency and compliance with the Quality Systems accreditation body/regulatory requirements
• Documenting defects and recommendations for improvement
• Reviews and revises facility quality documents to ensure they are satisfactory for customers and auditors
• Ensures the Quality System meets accreditation and certification requirements
• Serves as the principal contact with external auditors
• Preparing and presenting quality audit reports to senior management

Skills on Resume:

• Audit Assignment (Hard Skills)
• Compliance Resource (Soft Skills)
• Employee Training (Soft Skills)
• Document Review (Hard Skills)
• Defect Documentation (Hard Skills)
• Customer Compliance (Hard Skills)
• External Audit Liaison (Soft Skills)
• Report Presentation (Soft Skills)

Job Summary:

• Supporting the day-to-day Operations and wider business ensuring we are fully compliant with relevant legislative provisions as well as following internal policies and procedures
• Own the audit process, covering both brand and health & safety compliance, agreeing standards and approach with the senior management team
• Responsible for How To Procedures to ensure all shops, whether company owned or partner owned, can follow a set standards are followed by all
• Support quest for continuous improvement
• Follow up with any local authority enforcement visits and lead in any investigations 
• Coaching and supporting managers on compliance and brand standards
• Supporting in compliance training and workshops to ensure team meet company and legal standards
• Oversee compliance with licensing requirements
• Taking part and supporting in culture engagement activities to contribute to a happy, safe working environment
• Maintain and update all allergens & ingredient information and calorie detailing
• Work with new shop opening team to ensure the layout is compliant and all policies and procedures are in place prior to opening. 

Skills on Resume:

• Compliance Management (Hard Skills)
• Audit Coordination (Hard Skills)
• Policy Enforcement (Hard Skills)
• Continuous Improvement (Soft Skills)
• Investigation Leadership (Soft Skills)
• Manager Coaching (Soft Skills)
• Compliance Training (Hard Skills)
• Licensing Oversight (Hard Skills)

Job Summary:

• Execute accurate, objective and high quality social compliance assessments by implementing all requirements indicated in the client specific procedures, auditor training and audits scope.
• Prepare in advance by downloading and reading audit documents related to upcoming audits.
• Document and report the audit findings/observations.
• Communicate audit results to facility management in a professional, objective, and clear manner.
• Verify the effectiveness of corrective actions taken as a result of audit.
• Cooperate with and supporting other auditors and staff.
• Submit complete audit reports timely.
• Promptly address any clarification queries from the reviewing team.
• Complete all assigned training activities and actively participate in training sessions.
• Apply feedback from reviewers, training supervisor, quality manager and client facing team to future work for continuous improvement.
• Treat privileged information with discretion and ensuring all audit related documents and results remain confidential and well-guarded.
• Update country law profiles for assigned country/region in support of the audit process & advisory services and update appropriate tracking tools.

Skills on Resume:

• Compliance Assessment (Hard Skills)
• Audit Preparation (Hard Skills)
• Findings Reporting (Hard Skills)
• Clear Communication (Soft Skills)
• Action Verification (Hard Skills)
• Team Collaboration (Soft Skills)
• Report Submission (Hard Skills)
• Data Confidentiality (Soft Skills)

Job Summary:

• Recognizes and respects diversity among coworkers and customers
• Plans, conducts, documents and reports audits of Federal funds to assure compliance with law and professional practice.
• Meets with Chief Financial Officer to review federal compliance procedures, including allocation of responsibilities, accounts, internal policies, and governing rules and law.
• Reviews manual and computerized supporting documentation and reports to determine compliance with law and standards.
• Prepares exhibits such as external reporting statements, prepares work papers
• Determines propriety and proper reporting and legality of transactions
• Utilizes computerized equipment, where applicable, in the auditing process.
• Investigates cases of suspected fraud or abuse.
• Prepares reports of findings and conclusions and recommends corrective action. 
• Conducts follow-up audits to determine compliance with earlier recommendations for corrective action.
• Presents and defends audits, including the rationale for findings, conclusions, and corrective actions to the Chief Financial Officer and/or Controller.
• Conducts follow up audits, as needed, to monitor implementation of interventions and/or corrective actions.

Skills on Resume:

• Diversity Awareness (Soft Skills)
• Federal Fund Audits (Hard Skills)
• Compliance Review (Hard Skills)
• Documentation Analysis (Hard Skills)
• Fraud Investigation (Hard Skills)
• Report Preparation (Hard Skills)
• Corrective Actions (Soft Skills)
• Audit Follow-up (Hard Skills)

Job Summary:

• Carry out audits of the Quality, Health & Safety and Environmental Management Systems to verify compliance against defined standards and codes of practice.
• Perform internal audits in accordance with the internal audit programme and work with the Quality Team, Value Stream and other functional areas to ensure issues identified are resolved and closed out.
• Perform factory based Quality audits to verify compliance against defined standards, codes of practice and product specifications. 
• Facilitate the resolution and close out of issues / incidents which have been identified as part of audit or process monitoring activities.
• Collation and reporting of NCs to VS or relevant person
• Working with other site functional areas to ensure issues are investigated and corrective actions agreed and implemented.
• Close out of NC’s upon receipt of verified Corrective action.
• Continuously improve standards set and performance against those standards by participating in 8 Step Practical Problem Solving and other appropriate KPS methodologies with the value stream.
• Facilitate the implementation of Quality Standards by ensuring the necessary support is made available to the value stream and other functional areas.
• Provide training, support and guidance to the Value Streams to ensure standards are fully understood thereby enabling effective implementation.

Skills on Resume:

• System Audits (Hard Skills)
• Internal Audits (Hard Skills)
• Quality Compliance (Hard Skills)
• Issue Resolution (Soft Skills)
• NC Reporting (Hard Skills)
• Corrective Actions (Hard Skills)
• Standard Improvement (Soft Skills)
• Training Support (Soft Skills)

Job Summary:

• Executes elements of the annual audit plan.
• Responsible for performing specified audit procedures and the analysis of the audit results.
• Furnishes monthly reports of audit findings to the Director of Internal Audit & Compliance.
• Performs compliance testing of all regulatory elements identified in the annual Hospice Compassus work plan.
• Gathering data from billing reports and selecting a statistically random sample
• Distributing sample sizes to each company location
• Reviewing submitted documentation for completeness and compliance with technical elements
• Conducting audit field work
• Producing audit reports for the Director of Compliance & Internal Audit and Compliance Officer
• Providing feedback on audit findings within assigned regions
• Developing findings and recommendations for corrective action
• Tracking and trending audit findings across Programs and Locations
• Proactively cultivates and maintains strong, positive working relationships.

Skills on Resume:

• Audit Execution (Hard Skills)
• Results Analysis (Hard Skills)
• Report Furnishing (Hard Skills)
• Compliance Testing (Hard Skills)
• Data Gathering (Hard Skills)
• Field Audits (Hard Skills)
• Findings Feedback (Soft Skills)
• Relationship Building (Soft Skills)

Job Summary:

• Assist in the planning and execution of the supplier audit program.
• Complete audits and assessments of suppliers and service providers with respect to regulatory requirements and Quality Agreements and Specifications.
• Write and review Technical and Quality Agreements to ensure robust systems are in place with suppliers and service providers.
• Review and complete self-assessment and quality audit questionnaires from customers and Third-Parties.
• Perform internal audits and provide feedback to the Quality Audit Manager on the GxP compliance of systems and processes.
• Identify gaps and facilitate improvements to systems and processes to ensure adherence to current regulatory and GMP guidelines. 
• Ensure that audit findings and actions are addressed in a timely manner.
• Assist in the planning and execution of internal audit programs.
• Assist in the planning, organisation and execution of customer and regulatory inspections.
• Assess and review Quality records, for example CAPA's, Out of Specification investigations, controlled changes, and audit actions. 
• Facilitate their progress to resolution in a timely manner through communication with assignees and Quality personnel.

Skills on Resume:

• Supplier Audits (Hard Skills)
• Agreement Writing (Hard Skills)
• Self-Assessment Review (Hard Skills)
• Internal Audits (Hard Skills)
• Process Improvement (Soft Skills)
• Audit Follow-up (Hard Skills)
• Inspection Support (Hard Skills)
• Quality Record Review (Hard Skills)

Job Summary:

• Undertake special projects which have arisen through communication with the Head of Supplier and Customer Quality Assurance and the Quality Director.
• Write, review, endorse and authorise, as appropriate, SOPs, reports and Risk Assessments relating to the key duties and responsibilities of the job role and any relevant projects.
• Participate in meetings and working groups as the Quality representative relating to the key duties and responsibilities of the job role and any relevant projects.
• Deputise for the Head of Supplier and Customer Quality Assurance in meetings and take responsibility and accountability
• Maintain knowledge of appropriate scientific and technical developments and advise Senior Management of relevant trends.
• Provide support in an advisory capacity across the organisation with respect to specialist skills, expertise and knowledge.
• Ensure the integrity, confidentiality and safety of data and intellectual property of a patentable and proprietary nature.
• Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and appropriate staff, including Quality and Senior Management
• Plan, execute and complete supplier and service provider audits, including the preparation of audit reports, review of responses and audit closure.
• Plan and organise the timely review and approval of Quality and Technical Agreement
• Plan, execute and complete internal GxP audits, including the preparation of audit reports and progression of audit actions 

Skills on Resume:

• Special Projects (Soft Skills)
• SOP Writing (Hard Skills)
• Quality Representation (Soft Skills)
• Leadership Support (Soft Skills)
• Trend Analysis (Hard Skills)
• Advisory Support (Soft Skills)
• Data Integrity (Hard Skills)
• GxP Audits (Hard Skills)

Job Summary:

• Review the completion of Quality records, for example CAPA's, Out of Specification investigations, controlled change tasks, and audit actions. 
• Facilitate their progress to resolution in a timely manner.
• Liaising with suppliers and service providers with regard to the scheduling, completion, review and closure of external audits.
• Liaising with external organisations with regard to the completion and return of self-assessment and audit questionnaires.
• Liaising with suppliers, service providers and external organisations with regard to the completion and approval of Technical and Quality Agreements.
• Liaising with staff at all levels across site to facilitate the progression and completion of Quality records, for example CAPA's, Out of Specification investigations, controlled change tasks, and audit actions.
• Liaising with external organisations and regulators (e.g. MHRA and FDA) with regard to information requests.
• Planning, co-ordination and execution of supplier and service provider audits.
• Facilitating the completion and approval of Technical and Quality Agreements.
• Facilitating the completion of customer and third-party audit and self-assessment questionnaires.
• Planning, co-ordination and execution of internal GxP audit programs.

Skills on Resume:

• Quality Record Review (Hard Skills)
• Audit Scheduling (Hard Skills)
• Questionnaire Management (Hard Skills)
• Agreement Approval (Hard Skills)
• Stakeholder Liaison (Soft Skills)
• Regulator Communication (Soft Skills)
• Supplier Audits (Hard Skills)
• GxP Audit Execution (Hard Skills)

Job Summary:

• Performs the actual monthly underwriting quality audits to ensure compliance with underwriting guidelines and other departmental procedures to promote underwriting excellence within the organization.
• Performs the actual standard audits in most instances and special functions at the direction of the Chief Underwriting Officer or Chief Operating Officer.
• Organize data to generate standard and on request reports of audit findings for presentation and delivery to Department Managers, Senior Executives, and other internal groups.
• Works with the Department Managers to develop internal audit standards and procedures, including documentation, auditing criteria, forms, and specific focus areas to be covered
• Assists Department Managers in identification and development of underwriting file construction standards, trends and process improvement.
• Determines the content of the audit and number of files to be reviewed in each category.
• Coordinates and manages all external carrier insurance company audits.
• Communicates audit results action items to COO, CUO and monitors completion of identified follow up items.
• Immediately alerts Chief Underwriting officer of any critical findings.
• Protects the confidentiality of audit and other information learned by performing the duties of the position.

Skills on Resume:

• Quality Audits (Hard Skills)
• Special Audits (Hard Skills)
• Report Generation (Hard Skills)
• Audit Standards Development (Hard Skills)
• Process Improvement (Soft Skills)
• Audit Coordination (Hard Skills)
• Results Communication (Soft Skills)
• Confidentiality Protection (Soft Skills)

Job Summary:

• Responsible for building and/or revising internal audit checklists in accordance with applicable Regulatory bodies (FDA, AATB, ISO, NYDoH, Health Canada). 
• Responsible for the performance of internal audits to assess compliance to Company systems in accordance with said Regulatory bodies. 
• Responsible for the performance of vendor desk and on-site audits to assess the compliance of potential and existing vendors and their conformance to applicable Regulations and Company expectations. 
• Responsible for working with the Audit Program Manager to assess audit findings/ observations and report non-complying observations to appropriate management. 
• Responsible for the final documentation review for all donor lots to assess acceptability for the product’s Final Release to Distribution. 
• Responsible for recording and updating all relevant documentation as required by GMP regulations and industry practice. 
• Monitor and generate regular reports on insurance company financial ratings for compliance with company guidelines and reports adverse findings
• Assist Department Managers with special projects 
• Ensuring that the Quality Department remains in compliance with regulatory requirements.

Skills on Resume:

• Audit Checklist Creation (Hard Skills)
• Internal Audits (Hard Skills)
• Vendor Audits (Hard Skills)
• Findings Assessment (Soft Skills)
• Documentation Review (Hard Skills)
• GMP Compliance (Hard Skills)
• Financial Rating Monitoring (Hard Skills)
• Regulatory Compliance (Hard Skills)

Job Summary:

• Facilitates site preparations and leads auditing executions for Client audits and regulatory health authority inspections.
• Performs and leads internal Good Manufacturing Practices audits of all departments as required and prepares written report to document the findings.
• Performs and supports external Good Manufacturing Practices audits on packaging component, raw material suppliers, contract laboratories, etc. as required and prepares written report to document the findings
• Performs and leads site Fit and Finish Audits.
• Manages Audit Observations and Audit CAPA’s.
• Verifies and enforces implementation of procedures of external inputs in terms of legislation (directives, regulations, ICH, EMA, FDA, Health Canada, GMP) and corporate policies.
• Manages, maintains and verifies compliance with the Client’s CMCs and registration dossiers for drug products with internal company documents.
• Ensures familiarity with Health Canada, Food and Drug Administration (FDA), EMA, WHO and other regulations
• Leads GMP Compliance projects as assigned by quality management
• Manages monthly GMP Compliance metrics.
• Fosters co-operation and leads discussions to resolve issues with other functional areas 
• Assists with ongoing guidance and training of junior auditors

Skills on Resume:

• Audit Facilitation (Hard Skills)
• Internal GMP Audits (Hard Skills)
• External GMP Audits (Hard Skills)
• CAPA Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Dossier Verification (Hard Skills)
• Compliance Projects (Soft Skills)
• Auditor Training (Soft Skills)