QC Data Reviewer

Posted 09 Sep 2020

Madison, Wisconsin - United States

Req Id 209289

Details

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 performance materials. 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:

 

This position is a second-shift Monday - Thursday 10am-8:30pm position. 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 reviewing 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 may also be responsible for reviewing method qualifications/validations and equipment verifications.  You 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.  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, 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. 

  • 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)
  • Write stability protocols, maintain stability chambers/programs, review/manage stability reports, interact with customers to support stability program
  • 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
     
    Physical Attributes:
     
  • 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 capable of pushing and pulling heavy materials to complete assignments.  May lift 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
  • Work in a safe manner and maintain the cleanliness of the work environment
  • Work with highly potent / hazardous materials requiring the utilization of proper personal protective equipment which could include half/full face respirators, Saranex and / or Tyvek suits with powered respiration
  • May work in analytical testing labs with hazardous and toxic chemicals
     
     
    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

RSRMS

 


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!

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


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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