Abbott is looking for a Test Control Procedure (TCP) Specialist to conduct quality-related activities to deliver consistent, high-quality documents, services, products, and processes.
Requirements
- Working knowledge and application of business concepts, procedures and practices.
- Will perform this job in a quality system environment.
- Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment.
- Experience on LIMS system and capable for authoring test procedures in LIMS and understanding the process.
- Experience with IBM Cognos and/or Microsoft Power BI is a plus.
- Knowledge of regulations and standards affecting IVDs and medical devices, e.g. ISO13485.
Responsibilities
- Create, analyze and process electronic Quality testing documents in compliance with QSR, ISO13485 and other applicable standards.
- Initiate Document Change Requests and associated packages relating to electronic documents and verify for correctness of the submitted Change in alignment with testing site requirements.
- Participate in project teams to further develop efficient and effective electronic Quality testing and ancillary documents.
- Create, analyze and process electronic Quality testing and ancillary documents for new product development and on-market updates.
- Assist in defining and documenting departmental procedures and standards to meet Regulatory and Division requirements.
- Provide customers (internal) with technical assistance in development and execution of the electronic Quality testing document.
- Perform and support data mining activities.
Other
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Assist in resolving complex issues, provides judgment and recommendations to manager.
- Build and maintain successful cross functional relationships with internal departments such as R&D, Manufacturing, Quality Control, Regulatory Affairs and Operations.
- Be able to work with a diverse and dynamic international team providing support for multiple sites.
- Excellent written, verbal and interpersonal communication skills.
- Works effectively with others while providing high level customer service.
- Bachelor's Degree plus 2-5 years of related work experience with a good understanding of specified functional area, or an equivalent combination of education and work experience.
