What Does A Compliance Specialist Do?

WHAT DOES A COMPLIANCE SPECIALIST DO?

Published: September 24, 2024 - The Compliance Specialist investigates and responds to inquiries from internal departments and delegated entities regarding compliance issues. Conducting and documenting investigations according to established policies and procedures, this role ensures timely resolutions based on informed judgment. Additionally, the specialist manages databases of contractual and regulatory obligations while providing essential research support and collaborating with various teams to enhance the organization's compliance program.

A Review of Professional Skills and Functions for Compliance Specialist

1. Compliance Specialist Duties

Workflow Management: Track, amend, and document various aspects of departmental workflow.
Client & Consumer Support: Respond to and resolve daily requests from clients and consumers.
Project Completion: Complete various projects as assigned by management.
Data Research: Collect and research data, using intuition and experience to complement data.
Legal Knowledge: Maintain thorough knowledge of all reportable requirements under applicable laws.
Communication: Occasionally communicate with researchers, vendors, clients, and PMM staff.
Consumer Interaction: Interact with consumers disputing information.
Documentation Requests: Request documentation from clients and consumers.
File Retrieval: Obtain copies of files from original source providers.
Information Review: Examine information for grammatical, syntactical, and related errors.

2. Compliance Specialist Details

Complaint Management: Initiate, investigate, and respond to customer complaints.
Sample Inspection: Handle complaint sample receipt, initial inspection, and documentation verification.
Complaint Tracking: Initiate complaints in the TrackWise system and notify customers initially.
Sample Submission: Submit samples to the lab with a request for analysis.
Sample Coordination: Handle non-product quality-related samples associated with internal sample storage and coordinate with the off-site storage facility.
Sample Retention: Manage retained samples associated with complaint investigations.
Data Compilation: Compile and generate data in support of complaints, Continuous Process Verification (CPV), and Annual Product Reviews (APRs) for all commercial customers.
Batch Record Review: Conduct batch record reviews, gather data, and provide investigation-related support for complaints.
Technical Write-up: Investigate customer complaints and produce technical write-ups.
Data Analysis: Collect data, produce graphs/charts, summarize data, and merge it into uniform templates.

3. GMP Auditor and Compliance Specialist Responsibilities

Auditing: Conduct GMP audits as required per the annual audit schedule.
Inspection Readiness: Support in inspection readiness activities.
Risk Management: Ensure quality risk management is used and included as part of these audits.
Data Integrity: Ensure data integrity principles are included as part of these audits.
Audit Execution: Maintain qualified lead auditor status, schedule and perform audits, write audit reports, and monitor remediation through completion/implementation.
Supplier Audits: Conduct third-party audits of suppliers/contractors to ensure conformance with GMPs and related regulatory requirements.
Internal Audits: Conduct internal audits of site facilities, operations, procedures, and products, including data integrity risks and other quality risks from the perspective of patients.
Regulatory Support: Support preparing, organizing, and monitoring regulatory inspections.
Quality Systems Compliance: Ensure that quality systems comply with company standards and applicable regulatory requirements.
Risk Reduction: Facilitate the reduction of quality risks such as data integrity risks, supplied materials risks, process risks, and product risks through the GMP auditing function, with a focus on protecting patients from harm.
Training & Coaching: Implement inspection readiness activities, such as training, coaching, and mentoring functional areas in participating in FDA GMP site surveillance inspections.
Regulatory Inspections: Participate in regulatory agency inspections at PTx.

4. Compliance Specialist Job Summary

Document Management: Manage changes to various compliance documents.
Policy Communication: Facilitate updates and communication of changes in SFS Compliance policies and procedures, including the Investment Advisory Representative Compliance Guide, Investment Advisory Field Supervisory Guide, and Policy and Procedure Manual.
Administrative Liaison: Serve as administrative liaison between IA Compliance and the Law Department when updating brochures and agreements.
Document Annotation: Annotate documents with IA Analysts’ comments and ensure comments are implemented prior to finalization.
ADV Reporting Assistance: Assist with ADV reporting.
Data Analysis: Assist with gathering and analyzing data needed to accurately file ADV.
Data Management: Work with a large data file from IT, analyzing, scrubbing, organizing, and manipulating information to accurately report AUM and custody numbers.
Monitoring Reports Administration: Maintain and distribute various monitoring reports designed to track and remediate investment advisory concerns.
Monitoring Compliance: Monitor No Trade, High Cash, Share Class, Drift, and House Accounts.
Report Troubleshooting: Work under the direction of the compliance analyst to troubleshoot, evolve, and create monitoring reports to address technical difficulties and the evolving compliance landscape.
Audit Support: Serve as a key member in gathering, reviewing, and organizing requested documents and information for various audits.
Mailing Support: Assist with the creation and distribution of various client and field mailings.
Communication Facilitation: Help create, facilitate review, and coordinate the distribution of communications to interested parties.
Risk Management: Review data and rules to efficiently identify and manage risk.
Data Skills Development: Research and develop data management skills by reviewing data for trends and patterns.

5. Compliance Specialist Accountabilities

CAPA Management: Assure the overall quality and effectiveness of the deviation and CAPA process.
Continuous Improvement: Ensure that best practices are in place and seek continuous improvement while ensuring the right level (risk-based approach) of quality is applied.
Coaching & Performance Management: Assure capability building within Beem (including QA) through effective coaching, monitoring/reporting, and performance management.
CAPA Committee Support: Serve as the back-up for DCC for the CAPA committee and DRB.
Risk Reporting: Report local issues and risks related to the CAPA and deviation process to the DCC, including requirements for improvement or best practice proposals.
Self-Inspection Coaching: Support self-inspections by coaching the self-inspector during audits.
Validation Representation: Act as the validation representative for beem equipment.
Root Cause Analysis: Lead root cause investigation and impact assessment.
Documentation: Write CAPA and/or deviations in SAP.
GMP/EHS Support: Support the operational team in ensuring the compliance of GMP/EHS tasks (CAPA/deviation/change control/audit).
Inspection Support: Provide support for the LSPOC inspection by being a list key user, scribe, or coordinator, and assisting the beem teams in preparing for inspection and responses.

6. Compliance Specialist Functions

Licensing Management: Handle day-to-day processes related to SFC and HKMA licensing and registration matters for individuals, including applications, de-registration, regulatory notifications, and other reporting.
Management Accountability Support: Assist with the process for management accountability regime, including Chief Executive, Alternate Chief Executives, Executive Officers, Responsible Officers, s.72B Manager, and Manager-In-Charge appointments and regulatory submissions.
Regulatory Monitoring: Keep abreast of the latest licensing regulatory developments.
Regulatory Advisory: Provide regulatory advisory to the business on licensing matters.
Licensing Review: Perform periodic licensing reviews for SFC and HKMA individuals.
Process Improvement: Review processes to reduce operational risk and improve efficiency.
Stakeholder Liaison: Liaise closely with key stakeholders in Compliance, the business, and other control functions, and respond timely to related requests and inquiries.
Data Entry: Fill in part numbers, related parts, and new releases on compliance check sheets and/or diagnostic sheets.
Document Monitoring: Monitor documents to confirm data details and completion.
Work Order Response: Effectively respond to work orders in a timely manner.
Data Recording: Record, store, and retrieve all collected data electronically.
Data Accuracy: Ensure all recorded data is accurate before drawings are published.
Data Confirmation: Work closely with engineers to confirm data entry accuracy.
Data Processing: Navigate through the computer program to process data.

7. Compliance Specialist Job Description

Audit Management: Perform periodic audits on company procedures and processes and report on the organization’s compliance.
Compliance Issue Resolution: Identify, analyze, and resolve compliance issues.
Sales Support: Support the sales process by completing RFPs.
Policy Review: Ensure that all policies and standards are regularly reviewed and up-to-date.
Process Mapping: Keep the company’s process mapping and responsibilities structure chart up to date.
Policy Development: Develop and update existing compliance policies and related documentation.
Regulatory Research: Proactively research to stay up-to-date with regulations and rules.
Regulation Communication: Communicate regulations to internal and external parties.
Management Review Support: Assist with management review preparation.
Compliance Administration: Assist with administrative and organizational tasks related to the administration of Seres Compliance Program.
Record Management: Organize and update compliance records and databases.
Global Transparency Support: Aid in the implementation of the Global Transparency Program for collecting and reporting transparency data as required by applicable global “Sunshine” transparency laws and regulations.
Administrative Support: Support the Compliance department with administrative tasks including scheduling appointments, events, and other employee-based events.
Interview & Investigation Assistance: Schedule interviews and assist with investigations of potential compliance violations.
Presentation Development: Develop and prepare presentations.

8. Compliance Specialist Overview

Internal Audit Coordination: Coordinate and conduct internal compliance audits, document findings, and notify stakeholders and leadership of findings according to the Compliance Audit Work Plan.
Issue Resolution: Recommend solutions for noncompliance issues and follow up to ensure recommendations are implemented.
Data Tracking & Analysis: Track and trend data from audit findings to identify staff educational needs.
Compliance Training: Develop and present training and education related to compliance for ICHS staff.
External Audit Support: Provide support during external compliance and regulatory audits, including reviewing documents for accuracy, taking minutes during meetings, and uploading documents to regulators.
HIPAA Incident Management: Serve as the primary reviewer of potential HIPAA incident reports, conduct initial investigations, track case progress, take appropriate action, and escalate to the Corporate Compliance Officer as needed.
Release of Information Management: Coordinate the Release of Information (ROI) process and manage medical record requests related to subpoenas and other legal requests, and respond to patient rights requests under HIPAA in coordination with medical records programs.
Consent & Privacy Support: Develop resources and respond to consent and privacy-related questions and concerns within the organization.
Data Privacy Safeguards: Ensure safeguards are in place to prevent intentional or unintentional use or disclosure of protected health information.
Confidential Communication Management: Assure a confidential communications process for soliciting, evaluating, and responding to complaints and problems.
Regulatory Memo Tracking: Log, assign, and track HPMS memos and informational notifications from CMS and other regulatory agencies to ensure review and appropriate action.
Policy & HIPAA Support: Resolve questions and concerns regarding policies, procedures, and HIPAA, including those received through the compliance hotline.
HIPAA Training: Assist in the development and presentation of training and education related to HIPAA for employees, subcontractors, and other appropriate entities.
Committee Support: Prepare committee meeting packets, take minutes during compliance meetings, and provide general assistance.
Exclusion Screening: Conduct monthly exclusion screenings on contracted staff and vendors for the PACE program.
Compliance Documentation: Maintain appropriate documentation regarding the Compliance Program.

9. Compliance Specialist Details and Accountabilities

Project Optimization: Work with the compliance team members and project teams to remove any roadblocks and optimize project delivery for all compliance tasks.
Corporate Compliance Facilitation: Facilitate corporate initiatives on product, material, and environmental compliance.
Process Development: Develop and implement reliable processes that will ensure compliance.
Stakeholder Engagement: Engage with internal domains and key stakeholders to improve processes and ensure predictable delivery of tasks.
Product Compliance Specification: Develop product compliance specifications for products, materials, components, markings, labeling, and testing to meet legal requirements.
External Liaison: Liaise with external test laboratories, certification bodies (UL, CSA), and agencies to provide project services that deliver on time and on budget.
Test Strategy Development: Understand hardware requirements and design documents and develop comprehensive test strategies, procedures, and plans that ensure product compliance with system requirements.
Documentation Preparation: Prepare documentation packages for Type approvals.
Hardware Testing: Conduct hardware validation testing (electrical performance, environmental, and regulatory), component qualification, debugging of prototype hardware, investigation of design defects, and testing of design changes when required.
Product Testing: Perform detailed product testing at the system and component levels.
Process Improvement: Work continuously to improve compliance verification, homologation, and test processes.
EMC/EMI Expertise: Provide EMC/EMI test standard interpretation and testing expertise.
Design & Manufacturing Support: Offer design and manufacturing support regarding product performance, certification processes, wireless regulations, and safety certifications.
Collaboration: Form and defend educated opinions while collaborating with development teams to meet project objectives.
Supplier & Partner Interface: Interface with various suppliers, service providers, vendors, and industry partners to ensure product compliance.
Test Data Oversight: Oversee test data to validate conformance to legal and regulatory requirements.

10. Compliance Specialist Tasks

Sanctions Policy Support: Assist with implementing, maintaining, and updating the Sanctions Policies, Procedures, and Processes, and support the roll-out of a global Compliance Management System and key policies.
Local Compliance Adaptation: Support local and regional teams in tailoring policies to local laws, regulations, and business contexts.
Risk Assessment: Assess related sanctions risk exposure, oversee the quality of sanctions control processes, and help set global standards to manage and mitigate sanctions risks for Delivery Hero Group.
Control Analysis: Support the central compliance team with the analysis of existing controls to assess their effectiveness in meeting regulatory obligations and providing strong internal risk mitigation.
Documentation: Document the scope of work performed, recommendations for enhancement, and any regulatory exceptions.
Compliance Training: Train new and current personnel subject to the Sanctions Policies and other corporate compliance policies.
Compliance Monitoring: Conduct compliance risk-based monitoring, compliance risk assessments, and testing of compliance with internal policies, procedures, and guidelines.
Control Effectiveness Assessment: Assess the effectiveness of controls in meeting regulatory and legal obligations.
Process Improvement: Recommend remediation actions and enhance existing processes accordingly.
Regulatory Updates: Stay current on key Sanctions, Anti-Bribery & Corruption, Conflict of Interest, and other Compliance topics, regulatory changes, key enforcement actions, and related industry trends.
Report Preparation: Assist in preparing and reviewing reports, summarizing the objectives, scope, findings, and conclusions of completed testing, and developing action plans to remediate findings from the testing.
Compliance Point of Contact: Serve as the point of contact for all inquiries from within Delivery Hero Group related to compliance with economic sanctions or other compliance areas.
Misconduct Investigation Management: Manage and maintain the compliance response for non-compliant behavior and initiate steps for investigating misconduct (e.g., whistleblower hotline, internal investigations).

11. Compliance Specialist Roles

Supplier Follow-up: Follow through with suppliers to receive investigation results, planned actions, and closure of actions by requesting objective evidence.
Internal Audits: Conduct internal audits of manufacturing processes to ensure compliance.
Test Result Review: Conduct a review of testing results.
Goods Inspection: Review documents and complete the inspection of returned goods.
Compliance Requirements: Establish compliance requirements for methodology transfer from Research to Quality Control.
Documentation Interpretation: Interpret complex, explicit documentation to ensure quality standards and compliance.
Employee Training: Provide training to new employees.
Audit & Compliance Expertise: Become an authority on all things audit and compliance.
Risk & Control Assessment: Perform risk and control assessments to evaluate the design and operating effectiveness of internal controls.
Audit Coordination: Coordinate audit requests and meetings between system/control owners and internal/external auditors.
Compliance Tool Design: Translate business and control requirements into the design of features and enhancements in compliance tools.
Project Guidance: Participate in system development or acquisition projects and provide guidance to teams on risk and control considerations.
System Documentation: Document new systems, businesses, or acquired entities, including data mapping and flowcharting.
Issue Escalation & Remediation: Escalate issues to senior management, develop and negotiate remediation plans, and track issues to resolution.

12. Compliance Specialist Additional Details

Audit Scheduling: Schedule and conduct audits of departments according to CMS standards and company policies and procedures.
Compliance Inquiry Management: Investigate, respond to, and make decisions regarding inquiries from internal departments and delegated entities on compliance issues.
Investigation Conducting: Conduct and document investigations according to established policies and procedures in response to reports received via confidential helpline, fax, email, or in person.
Issue Resolution: Complete investigations and determine resolutions based on knowledge and judgment.
Contractual Obligation Management: Manage databases of contractual and regulatory obligations, incorporating updates and building proficiency in requirements to serve as a compliance resource.
Querying & Reporting Innovation: Innovate querying and reporting functions to meet turnaround times for cross-market guidance.
Research Support: Provide research support for multi-market surveys.
Contract Processing: Process contracts and renewals, manage the Homes Division contracts management system, and work with attorneys for reviews.
Regulatory Tracking: Track regulatory and industry changes, and draft and provide updates for partners.
Compliance Education Development: Assist in developing legal compliance educational programming.
Collaboration: Collaborate with attorneys, product teams, business teams, industry specialists, and leadership teams to achieve an outstanding in-house legal compliance program.
Platform Success Support: Be instrumental to the success of a rapidly growing, innovative platform.

13. Compliance Specialist Essential Functions

Training Follow-up: Responsible for tracking and first-level follow-up for new hire, annual, specialized compliance, and provider documentation training.
Sanction & Exclusion Checks: Perform monthly sanction and exclusion checks on all employees, contractors, and vendors.
Incident Investigation Support: Assist CPM with compliance incident investigations.
Compliance Poster Management: Ensure compliance action line posters are displayed in each facility and office.
Billing Audit Preparation: Prepare and analyze data for billing audits as directed by the Compliance Audit Manager (CAM).
Incident Management: Assist in maintaining the incident management database and prepare trend analysis.
Compliance Research: Perform research on various compliance topics and provide summaries as requested.
Dashboard Maintenance: Assist CPM and CAM in creating and maintaining dashboards of compliance metrics.
Document Editing: Utilize Adobe Acrobat Pro to edit anesthesia record forms as directed by CAM.
Drug Screen Sampling: Assist in the selection of monthly drug screen samples for Human Resources.
Meeting Preparation: Assist CPM with preparation for Standards and Executive Compliance Committee meetings.
Core Values Promotion: Promote NorthStar Anesthesia’s Core Values and Compliance Program.
Sanction Check Reporting: Prepare monthly reports of sanction checks, including the resolution of matches, ensuring all individuals and entities providing services for NorthStar are not excluded or debarred from federally funded health care programs.
Training Report Maintenance: Maintain ongoing training reports for all teammates and follow-up to ensure training is completed in accordance with policy.
Compliance Dashboards: Prepare monthly compliance dashboards and quarterly independent contractor reports.

14. Compliance Specialist Role Purpose

Compliance Review: Review and approve communications and advertising materials, including new and modified products, for compliance with applicable laws and regulations, and correspond with FINRA regarding submitted materials or general inquiries.
Client Support: Assist clients with advertising questions related to compliance regulatory requirements, evaluate materials against regulations, determine the relevance of materials, and interact with FINRA.
Client Relationship Management: Maintain client relationships by demonstrating the highest level of customer service and partnering with clients to provide advice on general compliance-related advertising questions, mutual fund disclosure requirements, etc.
Regulatory Monitoring: Monitor and perform research, analysis, and interpretation of published and proposed regulations.
Contract Document Management: Organize and maintain client-related contract documents, including selling agreements and security licenses for internal registered employees and external wholesalers.
Advertising Record Maintenance: Maintain accurate and current advertising records on behalf of clients to ensure proper record-keeping as required by the company and FINRA.
Client Audits: Conduct routine audits of assigned clients.
Representative Audits: Conduct annual representative audits of internal and external personnel and communicate findings.
Compliance Testing: Maintain daily contact with internal associates while performing routine compliance testing of policies and procedures.
Regulatory Inquiries: Contact FINRA as needed regarding inquiries concerning regulatory compliance requirements.
Broker/Dealer Coordination: Maintain regular contact with Broker/Dealer firms regarding selling agreements and other contract requests.

15. Compliance Specialist General Responsibilities

Project Support: Support project and continuous improvement changes in the packing department.
Quality System Coordination: Ensure on-time delivery of quality system workload through interfacing with department SMEs (subject matter experts).
Procedure Translation: Translate project-led changes to pack floor procedures, ensuring usability and accuracy.
Discrepancy Investigation: Investigate operational discrepancies and author investigational write-ups.
Regulatory Compliance: Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, and industry practices, as well as Industrial Excellence initiatives.
Investigative Documentation: Perform assigned investigations and document investigative work in the case management system.
Compliance Program Support: Support the Swedish Health Services workforce in implementing the Office of Compliance & Privacy Compliance Program Description and organizational policies and procedures.
Legal Interpretation: Interpret and advise on the application of state and federal laws such as HIPAA (Health Insurance Portability & Accountability Act), HITECH (Health Information Technology for Economic and Clinical Health), Stark, anti-kickback, fraud, waste and abuse, and antitrust.
Education Material Development: Assist with the development of compliance education materials and other program documentation.
Educational Presentations: Present educational materials to a variety of audiences.

Relevant Information

What Does A Compliance Associate Do?

What Does A Compliance Lead Do?

What Does A Compliance Officer Do?

What Does A Compliance Manager Do?