Senior Associate QC Scientist

Merck KGaA - Madison, WI

Full-time - Mid Level

Madison, WI

Chemical Manufacturing

About the position

Join EMD Serono and be part of a team that is dedicated to innovating with science and technology to enrich lives. Our purpose in Healthcare is to help create, improve, and prolong lives through the development of medicines, intelligent devices, and innovative technologies in therapeutic areas such as Oncology, Neurology, and Fertility. This role involves performing analytical testing of cGMP materials, ensuring data accuracy and quality, and maintaining a clean and audit-ready laboratory environment. You will also assist in training newer staff, perform peer reviews, and manage projects with minimal oversight. This position offers great opportunities for personal development and career advancement in a diverse and inclusive working culture.

Responsibilities

• Perform analytical testing of cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentation
• Assist with training of newer laboratory staff as needed
• Perform peer review
• Work in a safe manner and ensure the lab stays in an audit ready and clean state
• Maintain the laboratory by ordering reagents or supplies, ensuring clean glassware is available, disposing of waste properly, and completing general housekeeping chores
• Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
• Exercise judgment within generally defined procedures and practices
• Solve problems and make decisions with minimal assistance
• Maintain projects and timelines with minimal oversight
• Meet with internal project groups to keep projects on track
• Perform instrument Performance Verifications (PV) as needed
• Manage assigned change controls and CAPAs to ensure on-time completion
• Participate in OOS and OOT investigations via testing, good documentation, and assisting with identification of root causes
• Assist with writing and revision of SOPs including raw material specifications, intermediate specifications, final product specifications, and stability protocols
• Work cooperatively within the QC department and with other departments to achieve project goals
• Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicable
• Support all data integrity initiatives and strive for right first time

Requirements

• Bachelor's Degree in Chemistry, Biology or other Life Science discipline
• 3+ years' experience in a GLP or cGMP analytical laboratory environment

Nice-to-haves

• Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7
• Strong attention to details, communication skills both oral and written
• Knowledge and understanding of analytical chemistry techniques
• Perform work in analytical testing lab with hazardous and toxic chemicals

Benefits

• Diverse and inclusive working culture
• Opportunities for personal development and career advancement
• Commitment to diversity, equity, and inclusion