Scientist, Quality

at MilliporeSigma
Location Madison, WI
Date Posted May 13, 2021
Category Bioscience
Job Type Full-time
Address 645 Science Drive

Description

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.

 

Your Role:

You will be responsible for the review of sample analyses in the Quality Control department and all related paperwork. Data review will comply with all ALCOA+ requirements of analyses that may include HPLC, GC, IC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. You may also be responsible for method qualifications/validations and equipment verifications.  The position will be responsible for maintaining project timing/costs by interacting with internal/external clients to assure project goals are met. You will be responsible for writing protocols and standard operating procedures, deviation investigation, as well as out-of-specification/trend investigations.  You will be responsible for leading change controls with the Quality Control group and potentially interacting with vendors for software updates.

 

Other responsibilities include participation in process improvement initiatives, maintaining a clean and safe working environment, and supporting the department in maintaining the laboratory in an audit ready state. The Scientist, Quality position will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

  • Work on complex problems in which analysis of data requires an in-depth evaluation of various factors
  • Exercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining results
  • May determine methods and procedures on new assignments and provide guidance for new or less experienced personnel
  • Able to solve problems and make decisions with minimal assistance
  • Able to interpret analytical data (including FT-IR, 1H NMR, MS)
  • Perform review of analytical data for accuracy and quality
  • Train new or less experienced personnel in SOP content and data reviewer requirements
  • Meet with internal project groups to keep projects on track
  • Maintain projects and timelines with minimal oversight
  • Review executed method transfers into QC and write/review summary reports
  • Review method validation data and write technical reports
  • Review instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair data
  • Review in-process, final products, intermediates, and raw materials analyses. Testing will involve the use of HPLC, GC, IC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments
  • Participate in OOS investigations via testing and good documentation
  • Apply critical thinking and good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with minimal assistance from supervisor
  • Review reference standard requalifications and maintain reference standard inventory/documentation
  • Write and revise SOPs including raw material, intermediate, and final product specifications
  • Work cooperatively within the QC department and with other departments to achieve project goals
  • Communicate with project management and provide technical updates
  • 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
  • Work in a team environment

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in Chemistry, Biology, Biochemistry or related biological sciences
  • 5+ years in a GLP or cGMP analytical laboratory environment or equivalent industry experience

Preferred Qualifications:

  • Excellent written and verbal communication skills
  • Excellent documentation practices
  • Knowledge and understanding of organic analytical chemistry
  • Technical writing skills to generate project reports

 

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