At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Develops and Executes system related (i.e., hardware, software, labeling and/or assay) verification & validation and/or characterization protocols and supports data package summaries in accordance with
Identifies and confirms cause of instrument and assay issues, discrepancies, problems or complaints in accordance with governing procedures.
Moves the Complaint Handling investigation process forward to closure.
Core Job Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
Runs defined protocols / experiments and development of associated data packages and associated documentation.
Basic troubleshooting within single functional area and/or protocol.
Basic operation of instrument and repairs at customer replaceable level.
Applies quantitative methods, analyzes data, evaluates results, forms conclusions and provides/implements improvements.
Develop/modify and Maintain assay file data based on input from assay group
Verify content of assay files and ensure Assay File parameters meet system requirements
Release Assay Files per approved Design Control and Site procedures
Bachelors degree in Life Science or closely related discipline is desired; or relevant combination of education or experience.
0-2 years work experience in this job area.
Knowledge of regulations and standards affecting IVDs and Biologics.
Good Lab Practice, PC Skills (Word, Excel, Powerpoint), Data representation.
Can conduct work that conforms to the effectiveness of ADDs quality system.
Reviews, generates and documents Verification & Validation or Characterization related inputs.
Demonstrates use of experimental and data Analysis techniques including statistics, DOE and Six Sigma training.
Exchanges information with product team members, scientists, engineers, and other systems development personnel.
Proficient in operation of instruments, and repairs/replacement of CRU parts/sub-assemblies.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email