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Quality Assurance Supervisor
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.
At MilliporeSigma, the Quality Assurance Supervisor will work various internal departments to improve and execute processes in compliance with cGMP regulations in 21CFR 210, 211, Part 11 and in ICH Q7 while leading a team supporting QA Operations efforts at the site.
- Provide guidance for quality related issues at the site.
- Lead a team of 5-7 individuals supporting release efforts at the site.
- Support team members by fostering a quality culture.
- Monitor department and site KPIs.
- Manage weekly release expectations for the team.
- Write, review, and approve Investigations, OOS (out-of-specification), OOT (out-of-trend), CAPAs and Change Controls.
- Participate in internal/external audits as needed.
- Provide quality oversight and support for new product introductions as primary quality point of contact.
- Respond to quality-related customer questions.
- Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols, and other controlled documents under a Quality Managed System (QMS).
- Review batch records for completeness and accuracy based on GMP requirements to ensure acceptable product and process consistency.
- Interact with production and laboratory personnel to ensure adequate communication and feedback for quality-related services to internal customers.
- Monitor the floor for quality related issues and collaborate on resolution.
- Lead Process Improvement for Quality related initiatives/projects.
Who You Are:
- Bachelor’s Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science related discipline
- 5+ years industry experience
- Master’s Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science related discipline AND 2+ years industry experience
- 2+ years of leadership skills
- Knowledge of ICHQ7 and API knowledge or experience.
- Track Wise and SAP experience.
- Proficiency in MS Word, MS Excel, MS PowerPoint and the ability to learn new software.
- Excellent communication and customer interfacing skills.
- Excellent writing skills and experience writing technical documentation & reports.
- Ability to simultaneously manage multiple tasks/priorities.
- Good problem-solving skills, time management and negotiating skills.
- Data analysis, presentation, and experimental design knowledge.
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.
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. 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.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a 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.
Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html