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Quality Excellence Specialist

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.

 

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

 

Your Role:

You will perform a variety of tasks within the Global Quality organization, with specific responsibilities aligned to the Quality Excellence function. This includes authoring, reviewing and approving standard operating procedures, protocols, specifications, inspection readiness activities, driving global Quality Excellence initiatives, conducting audits and review/approval of various types of regulated documentation.

 

You will impact the results of the Process Solutions Services (PSS) Global Quality organization and influences a range of customer, operational, project activities of other stakeholder teams (e.g. Operations) and Quality Excellence initiatives; Solve problems of varying complexity by identifying and proposing solutions, and by analyzing information; author, review and approve controlled documents to comply with regulations; help drive global simplification and standardization by influencing and collaborating with key global stakeholders; and provide support with authoring, reviewing and approving standard operating procedures (SOPs), laboratory/batch records, and other quality records as required (electronic & paper).

  • Help drive standardization practices across PSS and champion procedure/process simplification
  • Utilize creative ways and methodologies for delivering written content. (example – visual flows, pictures, videos, etc.)
  • Generate high-quality, robust, succinct documents that can be executed globally by all end users
  • Promote the use and implementation of electronic records & other digital solutions
  • Help review and approve GXP documents against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking & manufacturing production records, validation files, quality records and certificates of analysis
  • Conduct laboratory inspections to include inspection readiness, commissioning and/or internal audits
  • Provide support for client regulatory submissions, client audits and supplier audits
  • Provide support with review and approve change control (GCC) records
  • Provide global support for regulatory inspections (including pre/post activities)
  • Participate in global projects and Quality Excellence initiatives as a Quality and/or Technical subject matter expert and drive discussions to build consensus across the business regarding Quality topics
  • Apply Operational Excellence methodologies to implement Quality Excellence initiatives.
  • Track and report project milestones, as required
  • Help monitor department’s performance, including tracking of On Time Delivery (OTD) and other appropriate metrics
  • Create and/or conduct training related to Quality Excellence and/or other Quality activities
  • Gather end user feedback on documentation to improve usability
  • Other tasks and responsibilities as appropriate or required
  • Travel to other global sites to support Quality Excellence if required

 

Minimum Qualifications:

  • Bachelor’s degree in a scientific discipline (i.e. Biology, Chemistry, etc.) or technical discipline (i.e. Chemical Engineering, Biotechnology, etc.)
  • 3+ years’ experience in Quality Assurance or related field within a GxP environment

 

Preferred Qualifications:

  • Influences global stakeholders to drive Quality Excellence initiatives
  • Knowledge and preferably experience with Operational Excellence methodologies.
  • Green Belt certification
  • Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity, etc.)
  • Excellent written/verbal communication and interpersonal skills

 

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.

 

Job Requisition ID:  215156
Location:  Rockville
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

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 HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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