Quality Scientist - Investigator

Merck • Saint Louis, MO

38d • Onsite

About The Position

The Quality Control Scientist at MilliporeSigma in St. Louis, MO (Cherokee) supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice (GMP) guidelines (ICH Q7), raw materials and drug products. In this role, you will lead OOS, OOT, and deviation investigations associated with release, stability, and in-process samples, as well as manage CAPA projects, effectiveness checks, and change controls. This position reports to the Senior QC Supervisor.

Requirements

• 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

Nice To Haves

• 5+ years of experience in the pharmaceutical, biopharmaceutical, or related industry, with knowledge of API manufacturing and testing
• Knowledge of 21 CFR 210, ICH Q7, GMP, FDA, ICH, OSHA, GDP, data integrity, and ALCOA principles
• Experience with OOS/OOT investigations, CAPA, non-conformance deviations, and technical documentation and reports
• Experience with Falcon/Veeva, Chromeleon, LIMS, SAP, Word, Excel, and PowerPoint
• Experience with Antibody Drug Conjugates (ADC)
• Strong technical, communication, customer interface, project management, decision-making, and organizational skills with the ability to work effectively in a team and independently with minimal supervision

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

Benefits

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

What This Job Offers

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