Quality Control Validation Scientist

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

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

The Quality Control Validation Scientist is a critical role within the QC department, responsible for executing analytical method validations to support the testing of raw materials, intermediates, stability samples, and finished goods. Operating strictly in accordance with ICH and cGMP guidelines, this position ensures all testing processes meet the highest regulatory standards for product quality and compliance.

• 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

Who You Are

Minimum Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or other life science discipline
• 5+ years of GMP experience in the pharmaceutical, biopharmaceutical or chemical industry

Preferred Qualifications:

• 2+ years of experience validating analytical methods and cleaning methods
• Experience performing, reviewing, and troubleshooting analytical methods for bio-organics, proteins, or bio-conjugate products, using techniques such as UV, HPLC, GC, iCE, CGE, and wet chemistry
• Strong background in technical writing, root cause analysis, and scientific reasoning
• Proven ability to communicate effectively within cross-functional teams and collaborate directly with external customers

Pay Range for this position: $64,900 - 107,900 annually

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!