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QC Stability Supervisor

 

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.

 

 

This role does not offer sponsorship for work authorization.  External applicants must be eligible to work in the US.     

 

Your Role:

The Stability Supervisor, Quality Control, leads the Stability Team within the Quality Control (QC) Department at MilliporeSigma, providing leadership to the Stability Team. The Stability Team is primarily responsible for all the stability programs and maintaining the stability chambers within MilliporeSigma's Madison and Verona sites. Analysis performed within the Stability Team involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR, and XRPD among other tests and instruments. 

The Stability Supervisor, Quality Control will ensure the Stability Team is compliant in the execution of all their analyses, with regards to regulatory requirements including oversight of the training program for QC personnel, support the maintenance and calibration of instrumentation, reference standard inventory program, and all support efforts undertaken in the testing of cGMP materials under defined stability protocols. Direct management, engagement, and development of QC are also primary responsibilities. Other responsibilities may 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.

 

  • Lead and coach the Stability Team to work on, and solve, problems independently, while also providing technical guidance to the team
  • Manage and assist the writing of stability protocols, maintaining stability chambers/programs, review/manage stability reports, and interact with internal and external customers to support stability program as needed
  • Guide the team to exercise judgment within broadly defined procedures and practices to select a technique, methods, and evaluation criteria for obtaining results
  • Responsible for OOS/deviations investigations with the Stability Team and ensure CAPAs are well defined and completed in time
  • Demand and guide the team to 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 the supervisor
  • Meet with internal project groups to keep projects on track & review analytical data for accuracy and quality.
  • Support instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair as needed
  • Manage requalification of reference standards and maintain reference standard inventory/documentation.
  • Write and revise SOPs within QC Department
  • Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7, 21 CFR Parts 11, 210, 211, and 820 (applicable sections) and ISO13485 as applicable
  • Work by FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines
  • Identify areas for improvement and take action to undertake them through leadership and delegation to other members of the department

 

Physical Attributes:

  • 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
  • Work with highly potent/hazardous materials, using proper PPE, which could include half/full-face respirators.
  • Sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods, speak, hear, taste, and smell
  • Lift and/or move up to 25 pounds unassisted, lift more poundage with assistance
  • Utilize close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus. 

 

Who you are:

Minimum Qualifications:

  • Bachelor’s Degree in Chemistry
  • 5+ years of cGMP pharmaceutical quality control laboratory experience 

 

Preferred Qualifications:

  • Excellent written and verbal communication skills, as well as excellent documentation practices and attention to detail 
  • Ability to act in a position of leadership and work in analytical testing labs with hazardous/toxic chemicals
  • Knowledge of Good Manufacturing Practices for pharmaceutical manufacturing (21 CFR 210 & 211) and/or Q7 Good Manufacturing Practice Guidance for API’s
  • Knowledge and understanding of organic analytical chemistry 
  • Adequate technical writing skills to author training memos and operating procedures 

 

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.

Job Requisition ID:  238598
Location:  Madison
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. 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.

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