Quality Specialist 3 - System Audits

Job description

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 Quality Specialist 3 performs a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation. Impacts the results of the Quality Assurance (QA) team and influences a range of customer, operational, project activities of Operations teams. Solves problems of varying complexity independently by identifying and selecting solutions and by analyzing information. May also support management in facilitating work assignments and training plans for system audits team. 

 

Essential Job Functions:

·  Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records
·  Review and approve validation documents against regulatory and internal requirements as to include, as applicable, requirements, risk assessments, protocols, testing, final/summary reports, trace matrix, etc. 
·  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 commissioning and/or internal audits
·  Provide support for client regulatory submissions, client audits and supplier audits with regards to validation activities
·  Review and approve change control (GCC) records
·  Represent quality in meetings with external parties, where appropriate
·  Provide support for regulatory inspections
·  Lead and/or participate in projects as QA subject matter expert and drive discussions to build consensus across the business regarding Quality topics

 

Who You Are:

Minimum Qualifications:

·  Bachelor’s Degree in a scientific field (e.g., Chemistry, Biology, etc.) or technical field (e.g., Chemical Engineering, etc.)
·  3+ years' experience in Quality Assurance or quality experience within a GxP environment

 

Preferred Qualifications:

·  GAMP knowledge
·  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 are met
·  Works with cross-functional teams and builds networks within QA and Operations departments
·  Collaborates with various teams to identify and implement improvements
·  Proficient knowledge and application of FDA and EU regulations (cGMP, GLP, Data Integrity)
·  Excellent communication and interpersonal skills

 

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!

 

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 Colorado or New York City, 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:  257955

Location:  Rockville

Career Level:  D - Professional (4-9 years)

Working time model:  full-time .buttontextf748fab0b60d052d a{ border: 1px solid transparent; } .buttontextf748fab0b60d052d a:focus{ border: 1px dashed #eb3c96 !important; outline: none !important; }

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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