QC Applications & Automation Specialist

Abbott; Madison (WI); On-site; USD 61,000 - 123,000; Full time

Job summary

Abbott in Madison, WI is seeking a QC Applications Specialist to lead and support quality control automation and data analysis initiatives. The role covers EFD forms, data trending, QC analysis workbooks, liquid handling scripts, and documentation aligned with cGMP/ICH guidelines.

You will collaborate across teams, apply SAS JMP or similar tools, develop validation protocols, and mentor colleagues while traveling up to 15% as needed.

Qualifications

• Bachelor’s degree in Analytical or Applied Chemistry, Molecular Biology, Biochemistry or related field is required, plus a minimum of 4 years’ experience in biotechnology; or Master’s degree or Ph.D. in Life Sciences, Mathematics, or related field plus a minimum of 2 years’ experience in biotechnology; Equivalent combination of education and experience may be considered.
• 1+ years of experience in SAS JMP or others statistical software for data trending, calculation, and evaluation.
• 1+ years of coding and scripting within software and statistical applications.
• 2+ years of experience in a GMP/ ISO13485 laboratory environment and strong documentation skills in accordance with GMP requirements.
• Strong working knowledge in using basic software applications including Microsoft Office and Excel.
• Authorization to work in the United States without sponsorship.

Responsibilities

• Support of EFD processes, form development, and expansion for Quality Control.
• 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 determined by Operations management.
• Perform other related duties as assigned by management.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Ability to develop and follow procedures or experimental plans.
• Ability to interface and work effectively within team and department, as well as all levels of the organization, vendors, customers, etc.
• Ability to effectively work on many complex and varied projects at one time, with frequent changing priorities.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 100% of a typical working day.

Skills

SAS JMP

JMP Script Language (JSL)

Data Trending

Statistical Analysis

Protocol Development

Team Mentoring

Education

Bachelor’s degree in Analytical or Applied Chemistry, Molecular Biology, Biochemistry, or related field

Master’s degree or Ph.D. in Life Sciences, Mathematics, or related field

Tools

SAS JMP

Excel

Job description

Abbott in Madison, WI is seeking a QC Applications Specialist to lead and support quality control automation and data analysis initiatives. The role covers EFD forms, data trending, QC analysis workbooks, liquid handling scripts, and documentation aligned with cGMP/ICH guidelines.

You will collaborate across teams, apply SAS JMP or similar tools, develop validation protocols, and mentor colleagues while traveling up to 15% as needed.