Senior Quality Assurance Associate Specialist

Posté 26 mai 2022

Lenexa, Kansas - United States

Demander un identifiant 248274

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.


The Senior Quality Assurance Associate Specialist will support the maintenance, development, and improvement of quality systems, such as auditing (internal, supplier and customer), training, process validation, cleaning validation, equipment qualification, change control, complaint handling, documentation control, management of deviations and complaints, CAPA Management and ensure MilliporeSigma’s compliance with government regulations. This includes coordinating with both suppliers and customer to develop consistent, efficient business practices that comply with related regulations. Specific job duties are:

  • Review controlled documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release
  • Report all process deviations and/or laboratory OOS results
  • Investigate QA-pertinent process anomalies
  • Recognize areas of quality systems that exhibit an opportunity for improvement (documentation management, Training, Regulatory submissions, 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
  • Maintain current understanding of quality systems for business units including DPM products and apply and interpret regulations in making business decisions and risk assessments
  • Prepare affidavits for export and miscellaneous regulatory statements as related to customer inquiries
  • Management of Export Certificates
  • Preparation of confidential and proprietary documents and agreement
  • Management of document storage and retrieval supporting the Lenexa site
  • Support the Management of Change Program for all product quality-related changes to training curriculums, documents, equipment, specifications, and methods
  • Support the Site as a Site Lead User (SLU) for EDMS, TrackWise, and Learning Management System
  • Interact with site personnel regularly to ensure adequate communication and feedback for quality related services to internal customers
  • Work with other departments or customers to resolve product or service problems to the benefit of the customer and the quality objectives
  • Participate in internal and customer audit programs
  • Manage and investigate nonconformities (Deviations) and Corrective and Preventative actions
  • Take part in and contribute to a safe working environment by following corporate and departmental safety regulations
  • Perform other job duties as needed

 

Who you are:
Minimum Qualifications:

  • Bachelor’s degree in Biology, Chemistry, or other Life Science disciplines
  • 1 + years of experience in Quality Assurance or Quality Control, GMP manufacturing and validation

OR

  • Associate degree in science or healthcare
  • 4+ years of experience in Quality Assurance or Quality Control
  • 1 +years’ experience in GMP manufacturing, validation, or functional area 

 

Preferred Qualifications:

  • Careful attention to detail
  • Strong investigation and problem-solving skills
  • Ability to make decisions using a risk-based approach
  • Advanced written skills for technical protocols and reports, as well as response customer letters
  • Familiarity with ISO 9001/2015, cGMP, EDQM Certificates of Suitability
  • Working knowledge of FDA and/or USDA regulatory requirements
  • Experience with Microsoft Access, Excel, and Word
  • Strong time management skills
  • Excellent interpersonal skills for interacting with many internal departments and management levels, along with customer, suppliers, and regulatory authorities

RSRMS


 

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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