Quality Control Scientist - Data Reviewer and Technical Writer

Posted 06 Apr 2022

Madison, Wisconsin - United States

Req Id 244867

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 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.


Your Role:

 

The Quality Control Scientist - Data Reviewer and Technical Writer 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/approval of protocols and standard operating procedures as well as technical reports. 

This position is also responsible for drafting and updating method operating procedures and final product specifications. The position also entails coordination of document workflows, excellent verbal and written skills, a high level of attention to details, and outstanding organizational skills. Metric tracking and the use of Microsoft office tools are vital to the success of this role. Other responsibilities include technical writing and review of deviations, 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 Quality Control Scientist - Data Reviewer and Technical Writer, like all positions at MilliporeSigma, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties which include:

 

  • Perform analytical data review of cGMP data in support of the quality control group to ensure accuracy and quality of data.
  • 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.
  • Able to solve problems and make decisions with minimal assistance.
  • Able to interpret analytical data (including FT-IR, 1H NMR, MS).
  • Review of deviations, change controls and CAPAs.
  • Outstanding communication and organization with an emphasis on technical writing and database management.
  • Apply problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with assistance from supervisor.
  • Meet with internal and external project groups to keep projects on track.
  • Maintain projects and timelines with minimal oversight.
  • 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.

 

Physical Attributes: 

 

  • Standing for long periods of time
  • Lifting and moving up to 50 pounds with the assistance of equipment or teammates 
  • Working with highly potent / hazardous materials
  • Utilizing proper personal protective equipment which could include but is not limited to respiratory protection such as dust masks, half/full face respirators, supplied air, etc., and full body protection such disposable coveralls, hazmat suits, etc.

 

Who you are:

 

Minimum Qualifications:

 

  • Bachelor’s Degree in Chemistry, Biochemistry, or other life science discipline.
  • 5+ years in a GLP or cGMP analytical laboratory environment.

 

Preferred Qualifications:

 

  • Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail.
  • Eagerness to work in analytical testing lab with hazardous and toxic chemicals.
  • Knowledge and understanding of analytical chemistry. 
  • Excellent technical writing skills and time management.

 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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