Senior Quality Specialist

Posted 01 Oct 2021

Rockville, Maryland - United States

Req Id 230645

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.

 


Your Role:

As the Senior Quality Specialist with MilliporeSigma, your role impacts 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. You will author, review and approve controlled documents to comply with regulations, drive global simplification and standardization by influencing and collaborating with key global stakeholders.

 

  • 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
  • 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 international and domestically (0-20% travel)

 

Who You Are:

Basic Qualifications:

  • Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) Degree in any science or technical discipline
  • 4+ years of experience in Quality Assurance or other Quality role within a GxP environment

 

Preferred Qualifications:

  • Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity, etc.)
  • 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.) preferred
  • Excellent written/verbal communication and interpersonal skills

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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