Compliance Specialist - (US-IL-Chicago - 60827)

Minimum Education: None
Job Type: Full Time
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Responsibilities : The Compliance Specialist performs quarantine tasks for nonconforming product. This individual ensures that material control meets current standards (e.g performing physical segregation of nonconforming product). Responsibility includes: -conducting regularly scheduled assessments of all storage areas to ensure area material control meets standards. -implementation and oversight of the Quality System for associated functional areas. -Applies the principles of quality systems and procedures in the area to ensure continuous compliance with Quality Systems Regulations and other regulatory requirements and standards. This will be accomplished through the completion of complex tasks and projects, internal audits and active participation in the Nonconformance, Corrective and Preventive Actions program (CAPA). Responsible for administrating nonconformances and ensuring the CAPA documents meet the standards for quality and remain in compliance. Individual will be directly responsible to ensure processes, procedures and documentation conform to all regulations. Takes initiative to be involved in decision making and provides recommends for improvements. -Composes, types, and organizes quality documents and databases. Verifies data accuracy and recognizes inconsistencies in the data.

Requirements :The successful candidate should have knowledge of regulations and standards affecting IVDs and biologics. Experience in a Medical Device Operations area (Manufacturing or testing) is required. The individual must have excellent oral/written communication skills, excellent organization skills, and the ability to multi-task and prioritize multiple projects. In addition, this individual will be responsible for ensuring the procedures are established, followed and maintained in compliance with documented procedures and regulations. Information administered and maintained by this position is critical for the management of the Quality System and needs to have this experience. It is also needed to support other parts of the business related to communicating Quality information. A minimum of a bachelors degree in Science related field (molecular biology/biology) plus a minimum of 1 year of experience in applying quality system principles (nonconformance, investigation, CAPA), or equivalent work experience (3-4 years)is required.

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