Global Business Services (GBS) within the Abbott Rapid and Molecular Diagnostics Division (RMDx) has a global accountability to deliver an exceptional customer experience and create business value through compliance, standardization, and data analytics. GBS fosters a collaborative, team-focused and winning environment where employees are accountable and encouraged to develop themselves. The RDNA Compliance Operations Specialist is responsible for ensuring our operational processes comply with all regulatory and policy standards. This role will develop, implement, and monitor compliance tasks or deliverables specifically tailored to our operations, helping to mitigate risk and ensure seamless regulations and internal policies.

Essential Duties and Responsibilities (Key Activities)

• Carries out duties in compliance with established business policies and procedures.

• Demonstrates commitment to the development, implementation, and effectiveness of applicable Quality processes as per ISO, FDA, and other regulatory agencies.

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.

• Develop, implement, and update compliance policies and procedures to ensure alignment with quality standards.

• Maintain accurate records of compliance activities, including audits, training sessions, and incidents of non-compliance.

• Provide support for Corrective and Preventive Actions (CAPA) and Quality Improvement (QI) initiatives to address compliance issues and enhance service quality.

• Assist in preparing for or participating in internal and external audits to ensure compliance with regulatory standards.

• Perform other duties and tasks as assigned.

Dimensions –Education/Experience/Skills

• Bachelor's Degree: Required, along with 2 years of experience in operations, process improvement, or quality. Alternatively, a High School Diploma with 5 years of experience in operations, process improvement, or quality is also acceptable.

• Regulatory Knowledge: understanding of quality regulatory objectives.

• Analytical Skills: Ability to analyze quality, policy, and procedures documentation.

• Attention to Detail: Keen eye for detail to ensure accuracy in compliance activities.

• Communication Skills: Strong verbal and written communication skills.

• Problem-Solving: Effective problem-solving skills to address compliance issues.

• Organizational Skills:Excellent organizational skills managingmultiple compliance tasks and deadlines.

• Ethical Judgment: Strong sense of ethics and integrity to uphold compliance standards.

• Interpersonal Skills: Ability to work collaboratively with different departments and provide guidance on compliance matters.

• Technical Proficiency: Familiarity with QMS Agile system, SAP,cor other ERP applications.

• Adaptability: Ability to stay updated with changing regulations and adapt compliance strategies accordingly