Senior Quality Specialist

Posté 27 juil. 2022

Rockville, Maryland - United States

Demander un identifiant 253652

Détails

 

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 individual performs 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.

 

This will be a hybrid role with 1-2 days per week onsite in Rockville, MD.

 

Essential Job Functions:

  • Author, review and approve standard operating procedures (SOPs), laboratory/batch records, and other quality records as required (electronic & paper)
  • Drive standardization practices across PSS and champion procedure/process simplification
  • Champion the use and implementation of electronic records & other digital solutions
  • Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking & manufacturing production records, and certificates of analysis
  • Review and approve validation files for equipment, systems and assays
  • Review and approve deviations / OOS records of varying impact and criticality
  • Conduct trend analysis for deviations and review / approve applicable CAPA records
  • Conduct laboratory inspections to include inspection readiness, commissioning and/or internal audits
  • Provide support for client regulatory submissions, client audits and supplier audits
  • Review and approve client and supplier quality agreements
  • Review and approve change control (GCC) records
  • Provide global support for regulatory inspections (including pre/post activities)
  • Lead and/or participate in global projects and Quality Excellence initiatives as a Quality subject matter expert and drive discussions to build consensus across the business regarding Quality topics
  • Create, track and report project milestones, as required
  • 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
  • Travel to other global sites to support Quality Excellence if required
  • Participate and/or lead other activities as required by Senior Management

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s degree in a scientific (i.e., Biology, Chemistry, etc.) or technical (i.e., Biotechnology, Chemical Engineering, etc.) field
  • 4+ years working in a combination of a Quality Assurance/Quality Control AND either laboratory and/or manufacturing within a GxP environment

 

Preferred Qualifications:

  • Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity, etc.)
  • Excellent written/verbal communication and interpersonal skills
  •  Acts ethically and ensures quality of own work and that of others
  • Open-minded, flexible and works with agility
  • Takes responsibility for ensuring that turnaround times & project timelines are met
  • Works with global cross-functional teams and builds networks within Quality, Operations & other key departments
  • Collaborates with various teams across PSS and Life Sciences to identify and implement improvements
  • Drives & implements change on a global scale
  • Acts independently and influences global stakeholders to drive Quality Excellence initiatives
  • Experience with Equipment Systems (Qualification, Validation, Calibration, Preventive Maintenance, etc.)

 


 

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 NYC, 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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