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Abbott · 6 hours ago

TCP Quality Documentation Specialist

Illinois, United States

Full-time

Onsite

Entry, Mid Level

$60K/yr - $120K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a TCP Quality Documentation Specialist to conduct quality-related activities, ensuring the effectiveness of the quality system and managing electronic Quality testing documents in compliance with applicable standards.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Responsible for implementing and maintaining the effectiveness of the quality system

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 resolving complex issues, provides judgment and recommendations to manager

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

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

Perform and support data mining activities

Qualification

Quality system implementationISO13485 knowledgeLIMS system experienceIBM CognosMicrosoft Power BIWritten communicationVerbal communicationInterpersonal skills

Required

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

Working knowledge and application of business concepts, procedures and practices

Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations

Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors

Exercises judgment within defined procedures and practices to determine appropriate action

Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment

Preferred

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

Excellent written, verbal and interpersonal communication skills

Works effectively with others while providing high level customer service

Benefits

Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with high employer contribution.

Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.