Senior Quality Assurance Specialist (Hybrid)

Posted 25 Mar 2024

St. Louis, Missouri - United States

Req Id 273091

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

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


Your Role:

The Senior Quality Assurance Specialist is a systems and product support role that will initiate and manage the implementation and maintenance of quality systems supporting operations, quality, and product compliance. This may include support and management of the Deviation and CAPA Program, Complaint and Customer Notification Program, Internal audit Program, Change Control Management, Document and Record Control, Training Program and product support functions supported by the Quality Systems. The Senior Quality Assurance Specialist is a highly motivated and meticulous individual with excellent problem-solving and communication skills. The Senior Quality Assurance Specialist responsibilities focus on enhancing manufacturing site by providing expertise in advanced problem solving and implementation of corrective and preventative actions. The Senior Quality Assurance Specialist works closely with internal team members, stakeholders, collaborators, and participating facilities to ensure that root cause analysis is conducted in a timely manner to achieve goals. Additional responsibilities include:

  • Provides Root Cause Analysis (RCA) support using performance improvement tools (e.g.,5 Why, Is/Is not, fishbone) and methodology, in addition to project management support for systemwide root cause analysis.
  • Utilizes project management tools and methodologies to track and communicate the status of RCA and provides regular updates to the RCA Teams, ensuring the team is informed of status updates of the root cause analysis.
  • Develops appropriate communication plans and strategies to ensure information is openly communicated.
  • Demonstrates leadership in developing and implementing quality system initiatives in areas of Operations and Product Support.
  • Recognize those areas of quality systems that exhibit an opportunity for improvement (ex. Documentation management, Training, Nonconformance management etc.) based upon business, customer, and regulatory requirements and develop, implement, and maintain these Quality Systems to ensure a level at or above industry standards.
  • Support the Development of project plans for specific quality system initiatives and process improvements.
  • Maintains current understanding of quality systems for business units and applies and interprets regulations in making business decisions and risk assessments. 
  • Establishes and maintains collaborative relationships within the system in order to obtain information and content from leaders and front-line staff to foster successful root cause analysis completion.
  • Act as initial contact with Product Engineering, R&D, Production, and other support groups requesting additional information for regulated products, product status, or quality support. 
  • Lead change team assessment of end-to-end impact for product, process, systems, assay/method, and equipment change controls.
  • Develops and manages best practices and tools for improvement, plan execution, and project management.
  • Support product initiatives or custom business opportunities.
  • Lead Administrative user for TrackWise Quality Management System Software.
  • Ensure personnel are treated with respect and dignity with an emphasis on providing a strong avenue for communication and company values.
  • Act as Lead Auditor of Internal Auditing Teams
  • Conduct Training (individual, group, departmental & the entire Quality System)
  • Participation in customer audits, regulatory audits, registration audits as a Subject Matter Expert of applicable Quality Management Systems

Who you are:

Minimum Qualifications:

  • Bachelor’s degree in Life Sciences discipline, (Chemistry, Pharmacy, Chemical or Process Engineering) along with 4+ years of experience in Quality System (i.e., ISO environment) with experience in a specific QA job function

or

  • Bachelor’s degree in any discipline along with 10+ years of Quality System (i.e., ISO environment) with experience in a specific QA job function

or 

  • Master’s degree or PhD Degree in Chemistry, Biochemistry, Biology, Pharmacy or Engineering along with 3+ years of Quality System (i.e., ISO environment) with experience in a specific QA job function

Location: onsite 3506 South Broadway, St Louis, MO - 3 days per week in office

 

Preferred Qualifications:

  • Knowledge of ISO 9001 and ISO 13485.
  • Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, IVDR, EDQM) related to biologic derived materials, and prior experience working in a controlled/regulated environment.
  • Current fine chemical industry knowledge &/or experience.
  • Excellent computer skills, including proficiency in MS Word, MS Excel, MS Access, MS Project, MS PowerPoint, and ability to learn and operate using other specific application software (SAP, Trackwise, etc.)
  • Excellent communication (verbal & written) and customer services skills
  • Excellent writing skills and experience writing technical documentation & reports
  • Ability to simultaneously manage multiple tasks/priorities
  • Excellent problem-solving skills/abilities
  • Good time management and negotiating skills
  • Capacity for independent work
  • Data analysis, presentation, and experimental design knowledge
  • Project management experience

 

RSREMD



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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

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


US Equal Employment Opportunities

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.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, 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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