Quality Control Data Reviewer

at MilliporeSigma
Location Madison, Wisconsin
Date Posted April 30, 2021
Category Bioscience
Job Type Full-time
Address Madison

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.

The Quality Control Data Reviewer position is responsible for the cGMP analytical data review and paperwork generated during laboratory analysis in the quality control division of MilliporeSigma. Data review may consist of all/some of the following; routine final product analysis, in-process tests, raw material analysis, method validation/qualification, cleaning, environmental monitoring and or other data generated to support quality control activities at the Madison and Verona sites. Review of data includes techniques specific to but not limited to HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. This position also is responsible for data review of protocols and standard operating procedures as well as technical reports.  Other responsibilities include 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, Sr position, like all positions at SAFC, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.

  • Perform analytical data review of cGMP data in support of the quality control group to ensure accuracy and quality of data.
  • 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 assistance.
  • Meet with internal project groups to keep projects on track.
  • Maintain data review turn around times and additional timelines with minimal oversight.
  • Support review of OOS and OOT investigations, deviations, change controls and CAPA’s
  • Apply problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor.
  • 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.
  • 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
  • Work in a safe manner and maintain the cleanliness of the work environment.
  • Work near moving mechanical parts.  May need to 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 when entering the laboratory.
  • Physical Attributes:
  • Sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time.
  • Lift and/or move up to 25 pounds unassisted
  • Push and pull heavy materials to complete assignments.
  • Lift more poundage with assistance.
  • Sense potentially hazardous situation
  • Utilize close vision, distance vision, color vision, peripheral vision, depth vision, and adjust focus.
  • Use phones, computers, computer monitors, and all office/laboratory equipment.
  • Type at a computer keyboard and can read CRTs/computer monitors.
  • Work at a desk as this is a non-lab position

Basic Qualifications:

  • B.S. in Chemistry, Biology, Microbiology, Chemical Engineering, or related biological sciences.
  • 2+ years in a cGMP analytical laboratory environment, non-lab or equivalent industry experience.
  • 1+ years of experience in technical writing and QC GMP data review

Preferred Qualifications:

  • Knowledge and understanding of organic analytical chemistry
  • Excellent written and verbal communication skills

Click here to learn more & apply today!