Quality Control Scientist, GMP API Investigations

MilliporeSigma; St. Louis (MO); On-site; USD 61,000 - 92,000; Full time

Benefits offered by this job

Health insurance

PTO (Paid time off)

Retirement contributions

Job summary

MilliporeSigma in St. Louis, MO is seeking a Quality Control Scientist to lead investigations (OOS/OOT) and CAPA programs under GMP guidelines. You will review data, author procedures, and collaborate with cross-functional teams to ensure product quality.

The role requires strong technical and communication skills, familiarity with TrackWise/LIMS, and experience in a cGMP lab environment. This position reports to QC management and offers a competitive salary.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or a life science discipline with 5+ years of experience in a cGMP testing laboratory environment
• OR
• Associate degree in Chemistry, Biochemistry, Biology, or a life science discipline with 10+ years of experience working in a cGMP laboratory environment

Responsibilities

• Manage and lead OOS, OOT, deviation, and CAPA investigations, including root cause analysis using tools such as 5 Whys and Fishbone diagrams and determination of corrective and preventive actions
• Interview QC personnel and collaborate with customers/clients, laboratory analysts, data reviewers, Manufacturing, Quality Assurance, Packaging, and Development to identify root causes and complete investigation reports in TrackWise
• Monitor and report metrics and trends related to non-conformances, CAPAs, quality events, and invalids
• Write, review, and approve operating procedures, specifications, OOS/OOT trend reports, and other QC-controlled documents
• Support analytical data review and quality review of documentation and processes for compliance with cGMP, internal procedures, and specifications
• Perform routine process audits and gap analyses while maintaining compliance with company policies, regulatory requirements, quality standards, safety policies, and cGMP requirements
• Perform additional duties as assigned by QC management

Skills

Root cause analysis

CAPA management

OOS/OOT investigations

Documentation review

Communication skills

Education

Bachelor’s degree in Chemistry/related field

Associate degree in Chemistry/related field

Tools

TrackWise

LIMS

SAP

Excel

PowerPoint

Falcon/Veeva

Job description

MilliporeSigma in St. Louis, MO is seeking a Quality Control Scientist to lead investigations (OOS/OOT) and CAPA programs under GMP guidelines. You will review data, author procedures, and collaborate with cross-functional teams to ensure product quality.

The role requires strong technical and communication skills, familiarity with TrackWise/LIMS, and experience in a cGMP lab environment. This position reports to QC management and offers a competitive salary.