Quality Assurance Specialist

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:

As a Quality Assurance Specialist in Madison and Verona, WI, you will be providing compliance oversight across the Millipore Sigma Quality Management System (QMS) in collaboration with site personnel.  A QA Specialist within the Compliance team provides broad compliance support to cross-functional teams in support of the following: quality management systems or processes such as deviation management, CAPA management, change control, risk management, data integrity, quality management and annual product reviews, supplier quality management, quality agreements, training, field corrective actions, coordination of and participation in regulatory and customer audits, complaint management and divisional policy implementation and compliance. In addition, the QA Specialist will be responsible for collaboration with the site personnel for ensuring that the site is in a continuous state of inspection readiness.  This position will use highly developed written and verbal interpersonal skills as they will be representing the Quality Assurance department and will be creating and updating the standard operating procedures (“SOP”).

 

·  Establish collaborative relationships with all departments within the organization to deliver on timely quality performance metrics within the QMS
·  Lead process control and monitoring of CTQ parameters and specifications
·  Lead the investigation, resolution, and prevention of product and process non-conformances
·  Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
·  Lead in the completion and maintenance of risk analysis
·  Work with design engineering in the completion of product verification and validation
·  Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
·  Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS)
·  Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
·  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
·  Identify and implement effective process control systems to support the development, qualification, and manufacture of products to meet regulatory requirements
·  Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

 

Who you are:

Minimum Qualifications:

·  Bachelor’s Degree in Engineering, Quality Management or Business Quality Management
·  2+ years of Quality Assurance experience working in a GMP Pharmaceutical environment
·  2+ Years of Quality Systems experience in disciplines such as change control, deviations, CAPA’s, APR’s, auditing, validation, auditing, Supplier Quality, and training 

Preferred Qualifications:

·  Detailed knowledge of cGMP and site quality systems while collaborating in a matrix environment
·  5+ years of Quality Assurance experience working in a GMP Pharmaceutical environment
·  5+ Years of Quality Systems experience in disciplines such as change control, deviations, CAPA’s, APR’s, auditing, validation, auditing, Supplier Quality, and training
·  Experience in leading and implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
·  ASQ, CQE, or other Quality-related certifications
·  Demonstrated experience in process optimization and/or improvement
·  Validation experience in a regulated manufacturing industry

 

 

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:  258061

Location:  Madison

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

Working time model:  full-time .buttontext1722e80f7dc3f6d2 a{ border: 1px solid transparent; } .buttontext1722e80f7dc3f6d2 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.

Notice on Fraudulent Job Offers
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Nearest Major Market: Madison
Job Segment: QA, Quality Assurance, Pharmaceutical, Lean Six Sigma, Microbiology, Quality, Technology, Science, Management