QC Data Reviewer - 5th Shift

Posted 19 Mar 2022

Madison, Wisconsin - United States

Req Id 244100

Details

 

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.    

 

 

 


Sign on bonus of $10,000 for 5th shift!

 

Your Role:

 

The QC Data Reviewer - 5th shift 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 QC Data Reviewer - 5th shift 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 turnaround 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.

 

  • Environmental Conditions: 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 requirements:  Regularly required to sit (~90% time), stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time.  Must occasionally lift and/or move up to 10 pounds unassisted to complete assignments.  May be required to lift more poundage with assistance. Specific vision requirements include close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus.  Regularly use phones, computers, computer monitors, and all office/laboratory equipment.  Required to type at a computer keyboard and can read CRTs/computer monitors.

 

Who You Are:

 

Basic Qualifications:

 

  • Bachelor of Science degree in Chemistry or other biological sciences
  • 2+ years in a cGMP analytical laboratory environment, or equivalent industry experience with a primary emphasis on data review

 

Preferred Qualifications:

 

  • Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail 
  • Knowledge and understanding of analytical chemistry techniques

 


 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Our Benefits - http://jobs.vibrantm.com/emd/content/Benefits-at-a-Glance/?locale=en_US

Curious? Apply and find more information at https://jobs.vibrantm.com

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.

 

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