Quality Control Validation Scientist — Method Excellence

MilliporeSigma; St. Louis (MO); On-site; USD 65,000 - 108,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Perquisites

Job summary

MilliporeSigma is seeking a Quality Control Validation Scientist to execute analytical method validations for raw materials, intermediates, stability samples, and finished goods in accordance with ICH and cGMP guidelines. The role emphasizes rigorous testing, method development, and technical documentation within a fast-paced QC environment.

Ideal candidates hold a chemistry-focused degree and 5+ years of GMP experience in pharma/biotech or chemical industries, with strengths in writing

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or other life science discipline.
• 5+ years of GMP experience in pharmaceutical, biopharmaceutical or chemical industry.
• Preferred: 2+ years validating analytical methods and cleaning methods.
• Experience with UV, HPLC, GC, iCE, CGE and wet chemistry.
• Strong technical writing, root cause analysis and scientific reasoning.
• Ability to communicate with cross-functional teams and external customers.

Responsibilities

• Perform analytical method and cleaning validations to support the release of commercial products, preferably with prior pharmaceutical industry experience
• Write method-specific protocols, standard operating procedures (SOPs), and comprehensive final reports for assigned validation projects
• Execute and review laboratory testing in strict accordance with Good Documentation Practices (GDP) and specific validation protocols
• Lead technical troubleshooting and process improvement initiatives to optimize laboratory performance, managing project milestones for internal and external stakeholders to ensure on‑time, high‑quality deliverables
• Draft and review analytical methods, equipment procedures, and operational protocols for non‑validated methods as assigned
• Perform technical reviews of assays and other GMP documentation while actively working in accordance with current cGMPs and championing proper laboratory safety and housekeeping practices

Skills

GMP experience

Technical writing

Root cause analysis

Scientific reasoning

Education

Bachelor’s degree in Chemistry or related life sciences

Job description

MilliporeSigma is seeking a Quality Control Validation Scientist to execute analytical method validations for raw materials, intermediates, stability samples, and finished goods in accordance with ICH and cGMP guidelines. The role emphasizes rigorous testing, method development, and technical documentation within a fast-paced QC environment.

Ideal candidates hold a chemistry-focused degree and 5+ years of GMP experience in pharma/biotech or chemical industries, with strengths in writing