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Quality Specialist 2
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.
You will perform a variety of tasks within the Quality Assurance department including conducting internal facility inspections, conducting audits and review / approval of various types of regulated documentation.
Responsibilities may include:
- Review and approve standard operating procedures (SOPs), laboratory / batch records, GMP part numbers, and other quality records
- Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis
- Review and approve validation files for systems and assays
- Review and approve minor, major and critical impact deviations / OOS records
- Conduct trend analysis for deviations and review / approve applicable CAPA records
- Provide support for client regulatory submissions, client audits and supplier audits
- Review and approve client and supplier quality agreements
- Perform routine inspections of the facility including cell banking and support areas for compliance to cGMP requirements and SOPs
Who You Are:
- Bachelor’s degree in a scientific (i.e., Biology, Chemistry, etc.) or technical (i.e., Chemical Engineering, Materials Engineering, etc.) field with 1+ years' experience within a GxP environment – OR –
- Associate degree in a scientific (i.e., Biology, Chemistry, etc.) or technical (i.e., Chemical Engineering, Materials Engineering, etc.) field with 3+ years’ experience within a GxP environment
- 1+ years of experience in a regulated environment
- Basic knowledge and application of FDA and EU regulations (cGMP, GLP)
- Strong oral and written communication and interpersonal skills
- Open-minded, self-motivated and works with agility
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.