This is a contract job opportunity. potential for permPosition : Senior Quality Assurance Compliance Auditor Drug Development 8926Location : Indianapolis INSchedule : M-F 8AM - 5PMProjected duration : 6 months + potential for permJob 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 workasidentifiedontheauditactivitylist
- ContributestoglobalQApoliciesoninterpretation / applicationofregulations
- ProvidesubjectmatterexpertisetoprojectsSupportteaminCAPAplancreation
- Hostsexternalaudits / inspectionse.g.regulatoryinspections,strategicclients.Assistswiththe facilitation of audit responses
- SupportstheQA to-QArelationshipwithkeyclient(s)
- Deliveryoftraininginperformanceofaudits(basic,intermediate,complex)
- Participate(formulti-regulatorytopicsinareaofexpertise)globalQualityinitiative(s)aimedat improving compliance and / or efficiency of the QA organization
- Supportsthereportingofqualitymetricsandimplementationofnecessarycorrectiveactions and / or process improvements via appropriate forum (e.
g. Monthly Reports, Site Quality Review, Liaison meetings)
- EnsureRegulatoryComplianceandQualityAssurance(RC&QA)responsibilities,asindicated in applicable controlled documents, are followed
- Otherdutiesasassignedbymanagement.
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.
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