This is a contract job opportunity. potential for perm

Position: Senior Quality Assurance Compliance Auditor Drug Development 8926

Location: Indianapolis IN

Schedule: M-F 8AM - 5PM

Projected duration: 6 months potential for perm

Job code: CVDJP00028926
Benefits are available
This is a hybrid position, where the candidate can work from home but will need to be in office when audits are being run, so candidates need to live within the Indianapolis area.
Essential duties:

• Conduct work as identified on the audit activity list
• Contributes to global QA policies on interpretation/ application of regulations
• Provide subject matter expertise to projects Support team in CAPA plan creation
• Hosts external audits/inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses
• Supports the QA-to-QA relationship with key client(s)
• Delivery of training in performance of audits (basic, intermediate, complex)
• Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and/or efficiency of the QA organization
• Supports the reporting of quality metrics and implementation of necessary corrective actions and/or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings)
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
• Other duties as assigned by management.

Summary:

The main function of a compliance analyst is to ensure the organizations operations and procedures meet government and industry compliance standards.

A compliance analyst may research regulations and policies, communicate requirements, and apply for compliance certifications on behalf of the organization.

Job Responsibilities:

Researching industry compliance regulations and policies.

Evaluating internal operational and procedural compliance.

Analyzing and updating existing compliance policies and related documentation. Communicating compliance policies and guidelines to Management and designated departments.

Developing and executing new compliance policies and procedures as required.

Applying for compliance certification and regulatory approval.

Developing and maintaining a compliance recordkeeping system.

Training employees on industry compliance requirements.

Maintaining communication with compliance regulators and following up on applications. Keeping up with compliance requirements and amendments to regulations. Requirements:

Industry related bachelors degree or related experience.

Compliance management certification preferred.

Knowledge of compliance management software.

Advanced analytical abilities. Good communication and interpersonal skills.

5-7 years of experience.