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Quality Assurance Membrane Facility Lead
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.
Quality Assurance Membrane Facility Lead
The Quality Assurance Membrane Facility Lead coordinates and leads the development of the QMS and regulatory requirements for the K3 Lateral Flow Membrane facility. Coordinates with Engineering on the C&Q execution and approval of C&Q protocols and reports. Identifies, drafts, updates and implements required Quality Procedures.
- Leads the design and setup of the QMS system for the new facility. Elements include, but are not limited to:
- Deviations/ Corrective actions
- Customer Notifications
- Shelf-life elements
- Business Continuity/ Contingency planning
- Data Integrity
- Leads general QA functions
- Drives the Change Control process, including customer qualification
- Performs risk assessments
- Provides input and guidance to the validation approach and VMP, including the support in drafting the VMP, validation protocols, and reports
- Drafts, updates and implements required quality procedures
- Ensures environmental controls/ monitoring/ contamination & pest controls
- Manages customer audits/ visits
- Prepares, schedules and hosts internal audits
- Develops shipping/distribution qualification requirements
- Coordinates the transfer of product specifications and provides support for the preparations and modifications of test methods
- Supports membrane pre-qualification
- Performs/oversees test result reviews of raw materials, in-process and final product sample inspections
- Leverages statistical controls; prepares Statistical Quality Control (SQC) reports
- Makes usage decisions
- Supports the release, storage, distribution, returns and destruction of materials
- Ensures conformance to MilliporeSigma Quality standards
- Leads start-up compliance audit and customer audits
- Performs quality checks and supports the data integrity program
Who You Are:
- Bachelor’s Degree in any discipline
- 3+ years of quality assurance or quality control experience
- Master’s Degree in Chemistry, Chemical Engineering, or other physical science discipline
- Strong technical background to interpret complex data
- Excellent problem-solving and organizational skills
- Project management skills
- Knowledge of and/or experience with ISO 9001; ISO 14001, ISO 13845
- Knowledge of SAP, JMP, LIMS
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.