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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.
The Quality Assurance Specialist is responsible for supporting the following systems: Document Control, CAPA (Corrective Action and Preventive Action) Program, Data Integrity, Procedure and Policy Implementation, and Internal Audits. The position is responsible for supporting the implementation and maintenance of the quality management system to ensure compliance to ISO 9001, ISO 17025 and ISO 17034, and ISO 17043.
The Quality Assurance Specialist will work closely with Regulatory, Production, Quality Control, Product Management and Service to support Quality System compliance and customer needs. Responsible for leading and sponsoring improvement initiatives and goals as directed by Quality Assurance Manager and Site Director. The purpose of this position is to provide guidance and support to the various teams to ensure the quality systems are maintained in accordance with procedures, provide independent and critical review of quality documents and records, support goals and improvement initiatives at the site in compliance with site and corporate goals, and support and lead rollout of local and corporate initiatives.
Specific responsibilities include:
- Directly involved in the review of open deviations, complaints, and CAPAs. Includes following up with area managers to ensure deviations and open action items are closed in a timely manner
- Responsible for the critical review of draft validation protocols and final quality assurance review of completed validations
- Responsible for performing critical review for final product release. Ensuring documentation is in alignment with documentation practices, procedures, specifications and methods
- Responsible for creating, revising, and reviewing SOPs (standard operational procedures) as needed
- Supporting established metrics and reports to track and measure the department’s productivity, efficiency, and performance to quality and other goals as agreed
- Assist with customer complaint investigations and write up of such investigations to ensure customer satisfaction
- Perform internal audits per schedule and in compliance with the site’s quality expectations and QMS (Quality Management System)
- Assist in preparation and hosting external audits and inspections
- Provide final QA approval of policies, procedures, protocols, specifications, suppliers, as assigned
- Work across departments and areas with other managers and staff to support the day-to-day aspects of the business, carry out company and corporate directives, meet company and corporate objective and to meet or exceed customer expectations
Who You Are:
- Bachelor’s degree
- 2+ years of work experience in an ISO-certified organization
- Bachelor’s Degree in Chemistry, Biology, or other life science discipline
- 2+ years of experience in life science manufacturing
- Prior experience with deviations, CAPAs, etc.
- Proficiency with SAP, Word, and Excel
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.