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Assurance Partner
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Quality Assurance Associate - Las Vegas, United States - Advatix
Description
Quality Assurance and Regulatory Compliance Associate Role Summary Our client seeks a quality assurance and regulatory compliance associate (QARC) to join their rapidly growing team.
This position serves as an interface for the Food and Drug Administration (FDA) and ISO and other state and local regulatory inspections and communications related to client needs.
The scope of the position includes ensuring that Quality Programs, systems for clients, and software meet all applicable regulatory requirements and are consistent with internal QA goals and initiatives.
This role is Key Results Area Manage and maintain the Quality Management System at the distribution centerEnsure the Quality Management System is maintained in support of the ISO Program for the client, including but not limited to an effective and compliant Corrective Action/Preventative Action Program (CAPA).
Verifies that appropriate follow-up and corrective action is taken because of audit observations and investigationsResponsible for adhering to and maintaining a standardized format and process for documenting the Company's Standard Operating Procedures (SOPs) and Work Instructions (WI) and ensuring that the associated document approval and control measures are being followed per the regulatory standardsCommunicate with Senior Management regarding the status of the Quality Management System, such as corrective actions, process updates, risk analysis, improvement initiatives, licensing, and other relevant informationFor the client's needs, lead internal and external preparations for ISO and other regulatory inspections; serve as the company interface on compliance matters and respond to inspectional observations; serve as lead Quality representative during client and health agency inspectionsAll other duties as assignedSkills & Qualifications A bachelor's degree preferred or relevant experience5+ years of QA or compliance experience with ISOExperience with maintaining Quality Management Systems, Document Control Systems, and other good quality practices in handling finished goods.
Experience with quality policies and metricsSSAE/SOC and ISO knowledge preferredXPDEL, Inc.is committed to an inclusive workplace that does not discriminate against race, nationality, religion, age, marital status, physical or mental disability, sexual orientation, gender, or gender identity.
We believe in diversity and encourage any qualified individual to apply. We are an EEOC Employer.
