|Date Posted||May 13, 2021|
|Address||645 Science Drive|
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
MilliporeSigma in Madison, WI is seeking a Scientist, Quality Associate Senior. In this role you will be responsible for in-process and final product testing. You will be responsible for the routine analysis of samples in the Quality Control department and all related cGMP paperwork. Analysis involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. This position is also responsible for assisting with raw material testing and release. Other responsibilities include 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.
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
- Exercise judgment within generally defined procedures and practices to select technique for obtaining solutions.
- Solve problems and make decisions with assistance.
- Write stability protocols, maintain stability chambers/programs, review/manage stability reports, interact with customers to support stability program as needed.
- Assist with development of testing methods to support cleaning verification program, validate or verify methods, and perform cleaning verification as needed.
- Perform preliminary review of analytical data for accuracy and quality.
- Help train new or less experienced personnel on procedures, analytical techniques, and methodologies.
- Meet with internal project groups to keep projects on track.
- Maintain projects and timelines with minimal oversight.
- Perform method validations/qualifications/transfers and write technical reports as needed.
- Perform instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair as needed.
- Demonstrate proper laboratory techniques during analytical testing for raw materials, in-process, final products, intermediates, and stability samples. Recognize problems with analytical test results or method performance and take appropriate steps to address them. Testing will involve the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
- Participate in OOS and OOT investigations via testing and good documentation.
- Apply good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor.
- Perform requalification of reference standards and maintain reference standard inventory/documentation.
- Write and revise SOPs including raw material, intermediate, and final product specifications.
- Document testing properly and in a timely fashion, including keeping laboratory notebooks accurate and up to date.
- 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
- Work in a safe manner and maintain the cleanliness of the work environment.
- Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.
Shift: Friday - Sunday 6:30pm-7:00am (evening shift)
- Regularly sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time
- Occasionally lift and/or move up to 25 pounds unassisted and push and pull heavy materials to complete assignments. Lifting more poundage with assistance
- Utilize speaking, hearing, tasting, and smelling
- Utilize close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus
- Environmental conditions: Work near moving mechanical parts. Frequently wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant sleeves, gloves, safety shoes) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles
- Work with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full face respirators
Who You Are:
- Bachelor’s Degree in Chemistry, Biology, Biochemistry, or related Science discipline
- 2+ years in a GLP or cGMP analytical laboratory environment
- Excellent written and verbal communication skills, as well as excellent documentation practices
- Ability to work in analytical testing labs with hazardous and toxic chemicals
- Knowledge and understanding of organic analytical chemistry