Quality Assurance Associate

Job Title- Quality Assurance Associate

Location-U.S-Homebased(Remote)

Summary

The Patient Support Services Quality Assurance and Compliance team is dedicated to ensuring the highest standards of quality and regulatory compliance. This team plays a pivotal role in maintaining the integrity of our document control processes, monitoring quality, supporting accreditation efforts, managing audits and quality issues and ensuring compliance and pharmacovigilance standards are upheld.

Job Overview

The Quality Associate will play a crucial role in ensuring the integrity and compliance of document control processes within our patient support services organization. This position involves managing, organizing, and maintaining documentation to support quality assurance and regulatory requirements. This entry-level position will primarily support the Quality team through effective document control, ensuring that all quality system documentation is accurately maintained, organized, and compliant. This role will also provide administrative support across other quality functions, including coordinating accreditation efforts across the organization, assisting with audits, tracking training records, and helping manage corrective and preventive actions (CAPAs). The ideal candidate will have a keen eye for detail, strong organizational skills, and a commitment to maintaining high standards of quality and eagerness to learn within a regulated environment.

Essential Functions:

• Document Control Management: Oversee the creation, revision, and archiving of quality-related documents, including SOPs, work instructions, and training materials. Ensure compliance with industry standards and regulatory requirements.
• Quality System Implementation: Adopt and implement the Quality Management System within the scope of the assignment. Support the assigned business line management and staff to enhance effectiveness.
• Stakeholder Collaboration: Cooperate closely with relevant business and other stakeholders to maintain focus on quality in program delivery. Inform the assigned business line and Quality Assurance of quality issues according to SOPs.
• Quality Assurance Execution: Execute quality assurance functions and support the implementation and adoption of Quality concepts within US Patient Support Services at the direction of Quality Leadership. Work closely with Quality Assurance and Compliance teams to execute quality document principles required by applicable SOPs.
• Quality Support and Reporting: May provide assistance during audits and regulatory inspections to the extent agreed, as required by applicable SOPs. Prepare periodic reports to stakeholders on quality-related matters, risk assessments, and specific quality improvement initiatives.
• Additional Responsibilities: Perform any other reasonable tasks as required by the role.

Required Knowledge, Skills, and Abilities:

• Knowledge of corporate standards and SOPs.
• Strong foundational organizational, interpersonal, and communication skills.
• Good judgment and decision-making skills.
• Meticulous attention to detail.
• Strong computer skills, including Microsoft Office applications.
• Excellent problem-solving skills.
• Ability to establish and maintain effective working relationships with co-workers, managers, and clients/customers.
• Knowledge of regulatory requirements and standards (e.g., FDA, ISO).
• Familiarity with patient support services and healthcare industry practices.
• Self-starter with the ability to work independently and take initiative.

Education and Experience:

• Required: Bachelor's Degree or equivalent combination of education, training, and experience.
• Preferred: Minimum of 2 years of experience in document control or quality assurance, preferably in a healthcare or patient support services environment.
• Preferred: A certification from a recognized professional quality or process improvement organization.

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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com