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Quality Assurance Specialist
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.
At MilliporeSigma, the Quality Assurance Specialist provides compliance oversight across the MilliporeSigma Quality Management System (QMS) in collaboration with site personnel. As a QA Specialist you are responsible for the implementation and maintenance of Quality Systems and processes to ensure internal and external compliance and the promotion of quality practices that meet or exceed required guidelines and regulatory requirements. Responsibilities include maintenance and continuous improvement of the overall Quality Program.
- Improve quality systems in ISO and non-GMP production environments
- Knowledge and experience with processing change controls in a regulated environment
- Communicate the status of operations and bring critical deviations to the attention of your manager
- Complete and have accurate work consistently with quality guidelines
- Assist in maintaining department critical metrics through on time CAPAs, Deviations and Complaints
- Assist in compliance with Life Science and site quality policies and procedures
- Represent the site during customer and regulatory audits
- Perform internal audits and assist in the investigation of customer complaints
- Contribute to Root Cause Investigations & Efficiency Checks of Nonconforming Incidents
- Conduct Quality System Training
- Document control activities to include management of the electronic documentation management system, and the ability to write, review or approve Operation Procedures, Specifications, Master Manufacturing & Packaging Procedures and other controlled documents
Who You Are:
- Bachelor’s Degree in Chemistry, Biology, or other Life Science field and 3+ years of experience in an FDA, ISO, or other highly regulated environment
- High school diploma or GED and 7+ years of Quality Assurance or Quality Control experience in an FDA, ISO, or other highly regulated environment
- Master’s Degree in Chemistry, Biology, or other Life Science field
- Current fine chemical industry knowledge &/or experience
- Knowledge of ISO 9001 and ISO 13485 and regulatory compliance issues (i.e., FDA, USDA, ICH, EDQM, IVDR) related to biologic derived materials
- Proficiency with SAP and Trackwise
- Proficiency in MS Word, Excel, Access, Project and PowerPoint
- Excellent verbal and written communication skills, including writing technical reports
- Ability to simultaneously manage multiple tasks/priorities
- Problem-solving, time management and negotiating skills
- Ability to work independently
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.