Your Role:The Scientist, Quality Associate Senior 3rd shift position performs cGMP analytical laboratory analysis in the Quality Control department of MilliporeSigma at both the Madison and Verona sites with a working schedule of 10:00pm-8:30am Monday, Tuesday, Wednesday and Thursday. 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 have a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties. Employee will adhere to the GMP requirements defined within 21 CFR parts 210 &211, 820, ICH Q7, Safety standards set under ISO 14001 & 45001.
- Perform accurate analytical testing of cGMP materials, including samples and reference standards, using proper laboratory techniques and documentation.
- Conduct peer reviews and support training for new laboratory staff.
- Maintain a safe, clean, well-organized, and audit-ready laboratory, including supplies, glassware, waste disposal, and housekeeping.
- Analyze data, troubleshoot diverse problems, exercise sound judgment, and make decisions with minimal supervision.
- Manage assigned projects, timelines, internal meetings, change controls, and CAPAs to ensure timely completion.
- Perform instrument performance verifications and support OOS/OOT investigations, including testing, documentation, and root-cause analysis.
- Write and revise SOPs, material and product specifications, and stability protocols.
- Collaborate across QC and other departments while complying with ICH Q7, 21 CFR Parts 11, 210, and 211, data-integrity requirements, and right-first-time practices.
Physical Attributes:
- Work in an analytical testing lab with hazardous and toxic chemicals.
Who You AreMinimum Qualifications:- Bachelor's degree in Chemistry, Biology or other Life Science discipline.
- 3+ years experience in a GLP or cGMP analytical laboratory environment.
Preferred Qualifications:- Understanding of 21 CFR Part 11, 210 and 211, and ICH Q7.
- Excellent written and verbal communication skills, as well as good documentation practices and attention to detail.
- Knowledge and understanding of analytical chemistry techniques.
Pay Range for this position: $32-$49 per hour.
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click
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