QC Data & Automation Specialist

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

Job summary

Abbott in Madison, WI, seeks a QC Applications & Data Specialist to lead quality control automation, data trending, and analysis workbooks. The role includes protocol development, validation, and documentation aligned with cGMP/GLP guidelines.

The ideal candidate brings SAS JMP experience, scripting skills, and strong data interpretation abilities, with travel up to 10% regionally and 5% off-site.

Qualifications

• Bachelor’s degree in Analytical or Applied Chemistry, Molecular Biology, Biochemistry or related field is required, plus 4+ years in biotech.
• 1+ years of experience with SAS JMP or similar statistical software for data trending and evaluation.
• 1+ years of coding and scripting within software and statistical applications.
• 2+ years in GMP/ISO13485 lab environment with strong documentation.
• Proficient in MS Office and Excel.

Responsibilities

• Lead and participate in QC applications and automation projects as described.
• Develop, validate, and implement QC Analysis Workbooks for data evaluation.
• Draft and review quality documents (SOPs, Test Methods) compliant with cGMP/GLP.
• Support CAPA and deviation reporting related to QC applications.
• Travel up to 10% between local Madison locations and 5% away as needed.

Skills

SAS JMP

Data trending

Statistical software

JSL coding

Education

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

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

Tools

JMP Script Language (JSL)

Excel

Microsoft Office

Job description

Abbott in Madison, WI, seeks a QC Applications & Data Specialist to lead quality control automation, data trending, and analysis workbooks. The role includes protocol development, validation, and documentation aligned with cGMP/GLP guidelines.

The ideal candidate brings SAS JMP experience, scripting skills, and strong data interpretation abilities, with travel up to 10% regionally and 5% off-site.