Impactful QC Validation Scientist - Analytical Methods

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

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Other perquisites

Job summary

MilliporeSigma in the United States is seeking a Quality Control Validation Scientist to execute analytical method and cleaning validations supporting release of products. Work strictly under ICH and cGMP guidelines, ensuring tests meet regulatory standards for quality and compliance; contribute to writing protocols, SOPs, and final reports.

Minimum qualifications include a Bachelor's in a life science and 5+ years GMP experience; preferred experience validating analytical methods; strong

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or life science discipline
• 5+ years of GMP experience in the pharmaceutical, biopharmaceutical or chemical industry
• Experience validating analytical methods and cleaning methods
• Strong technical writing and communication skills

Responsibilities

• Perform analytical method and cleaning validations to support the release of commercial products
• 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 GDP and specific validation protocols
• Lead technical troubleshooting and process improvement initiatives to optimize laboratory performance
• 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 upholding cGMPs and laboratory safety

Skills

GMP experience

Analytical method validation

Education

Bachelor’s degree in Chemistry or life sciences

Job description

MilliporeSigma in the United States is seeking a Quality Control Validation Scientist to execute analytical method and cleaning validations supporting release of products. Work strictly under ICH and cGMP guidelines, ensuring tests meet regulatory standards for quality and compliance; contribute to writing protocols, SOPs, and final reports.

Minimum qualifications include a Bachelor's in a life science and 5+ years GMP experience; preferred experience validating analytical methods; strong