Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Position Overview:
The QC Applications & Data Specialist will lead and/or participate in a variety of Quality Control functions relating to the automation and applications in use, including but not limited to, the Electronic Form Database (EFD), Data Trending, QC Analysis workbooks, Liquid Handling Automation Method Scripts, and quality documentation generation. The position is responsible for implementation, tracking, trending, and reporting on these processes.
Essential Duties:
Include but are not limited to the following:
- Support of EFD processes, form development, and expansion for Quality Control. Subject Matter Expert in new, or updates to, test method EFD forms and their implementation.
- Leads or supports project activities associated with Quality Control Applications and Automation, which may include leading the creation and/or implementation of liquid handling method scripts.
- Utilize basic knowledge of statistics and interpretation of analyses to draw conclusions from data summaries.
- Support or lead the development, validation, implementation, and improvements of test method specific QC Analysis Workbooks for data evaluation and disposition using SAS JMP Statistical Software, or similar software.
- Participates in Deviation report generation and CAPA efforts pertaining to QC Applications used.
- Lead and/or mentor individuals to complete essential tasks relating to the QC applications and automation.
- Draft and execute protocols for quality system software or analysis workbook Validation efforts in accordance with internal procedures, cGMPs, FDA, and ICH guidelines.
- Write, update, and review of quality documents, including but not limited to, Standard Operating Procedures and Test Methods that are compliant with cGMP/GLP guidelines.
- Provide support in cross functional teams, as required.
- Support and comply with the company's safety and environmental procedures.
- Support the Operations department in other non-laboratory functions, as de