QC Ops Specialist: Data-Driven Quality & CAPA

MilliporeSigma; Verona (WI); On-site; USD 63,600 - 95,500; Full time

Job summary

MilliporeSigma in the United States seeks an Operations Specialist in Quality Control to support planning, execution, and governance of QC quality systems projects. You will apply knowledge of analytical workflows and instruments (HPLC, GC, KF, DSC, NMR, LC-MS) to evaluate changes and drive process improvements while working with minimal supervision.

The role emphasizes audit readiness, deviation management, KPI reporting, data integrity, and cross‑functional digitization across QC systems such

Qualifications

• Bachelor’s degree in a Life Science discipline and strong GMP background.
• 5+ years in a cGMP analytical lab environment.
• Preferred cross-functional experience and shift coverage.

Responsibilities

• Drive continuous improvement by leading cross‑functional teams to implement system enhancements and training.
• Manage deviations, investigations, CAPA, audit responses, and change controls in QC with timely closure.
• Identify and report KPIs to site management for data‑driven decisions and performance tracking.
• Participate in data integrity initiatives within QC functions.
• Support digitization efforts in QC (e.g., LIMS, Chromeleon) and related software.
• Draft and review QC SOPs, technical reports, user requirements, and ALCOA+ documents.
• Represent QC on interdepartmental projects and coordinate with stakeholders.
• Adhere to GMP requirements per 21 CFR parts 210 & 211, 820 and ICH Q7; follow ISO 14001/45001 safety standards.

Skills

cGMP analytical laboratory experience

Cross-functional collaboration

Multi-project management

MS Office proficiency

Education

Bachelor’s Degree in Chemistry, Biology, or Life Science

Master’s Degree in Chemistry, Biology, or Life Science

Tools

STARe

Ommnis

Diffracto

Chromeleon

LIMS

Job description

MilliporeSigma in the United States seeks an Operations Specialist in Quality Control to support planning, execution, and governance of QC quality systems projects. You will apply knowledge of analytical workflows and instruments (HPLC, GC, KF, DSC, NMR, LC-MS) to evaluate changes and drive process improvements while working with minimal supervision.

The role emphasizes audit readiness, deviation management, KPI reporting, data integrity, and cross‑functional digitization across QC systems such