QC Scientist - Saint Louis, United States - Actalent

Description

Description:

• Bachelor's degree preferably in Chemistry, Biochemistry, or Biology
• Perform HPLC/UPLC testing on various samples including In-Process DS release, DP release, DS stability, DP stability, process validation, analytical method validation/transfer, method establishment/qualification, and other non-routine samples
• Demonstrate proper laboratory safety and housekeeping practices through regular 5S Lab audits and monthly inspections
• Conduct GMP testing using HPLC and UPLC test methods
• Accurately record and report analysis results following lab procedures
• Recognize and report out-of-specification results, suggesting solutions
• Maintain and troubleshoot analytical instrumentation and workspace
• Author and/or review SOPs, test methods, forms, etc., in the document management system
• Work in compliance with SOPs, GMP, GLP, and safety guidelines
• Collaborate with internal and external stakeholders for issue resolution and program health
• Minimum 1 year of HPLC/UPLC experience in quality/analytical/pharmaceutical industry
• Experience with a variety of HPLC/UPLC assays is a plus
• Prior use of EMPOWER
• Knowledge of GMP regulations in cGMP manufacturing environment
• Knowledge of analytical techniques and strong problem-solving skills

Additional Skills & Qualifications:

• Strong knowledge of chemistry and chromatographic analytical technologies
• Understanding of quality and regulatory requirements in the pharmaceutical industry
• Effective problem-solving, multitasking, interpersonal, and communication skills
• Ability to interpret technical procedures and regulations, and write/review procedures and test methods
• Apply mathematical operations for analytical tasks
• Drive functional, technical, and operational excellence