Quality Control Associate Scientist, Senior

 

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 Scientist, Quality Associate Senior position is responsible for the cGMP analytical laboratory analysis in the Quality Control department of MilliporeSigma. Analysis may consist of all/some of the following: incoming raw material analysis, in-process testing, final product analysis, method validation/qualification, cleaning, and environmental monitoring to support Quality Control activities at the Madison and Verona sites.

Analysis includes techniques specific to, but not limited to: HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. Other responsibilities may include initiation and review of deviations, OOS/OOT’s, change controls, and CAPA’s. Additionally, participation in process improvement initiatives, working in a team environment, maintaining a clean and safe work area, and supporting the department in maintaining the laboratory in an audit ready state are other duties. The Scientist, Quality Associate Senior position will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

 

Key Accountabilities:

• 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
• Performs 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

Scope of People Responsibility: Employee is responsible to adhere to the GMP requirements defined within 21 CFR parts 210 &211, 820, ICH Q7, Safety standards set under ISO 14001 & 45001.

 

Physical Attributes: 

• Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for at least 50% of the day.