Quality Control Validation Scientist

Merck • Saint Louis, MO

2d

About The Position

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.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or other life science discipline
• 5+ years of GMP experience in the pharmaceutical, biopharmaceutical or chemical industry
• Proven ability to communicate effectively within cross-functional teams and collaborate directly with external customers

Nice To Haves

• 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

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

Benefits

• health insurance
• paid time off (PTO)
• retirement contributions

What This Job Offers

• Job Type: Full-time
• Career Level: Senior