What are the responsibilities and job description for the Quality Assurance Supervisor position at MilliporeSigma?
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
MilliporeSigma has a Quality Assurance Supervisor in our exciting cGMP work environment. You'll lead the charge in ensuring excellence and innovation while having a blast along the way!
As the Quality Assurance Supervisor, you'll be the driving force behind our commitment to current Good Manufacturing Practices (cGMP) regulations in 21CFR 210, 211, Part 11 and in ICH Q7 . With your keen eye for detail and dynamic leadership skills, you'll inspire a team and foster a culture of quality and collaboration.
Minimum Qualifications:
Apply now and become a part of our diverse team!
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
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
MilliporeSigma has a Quality Assurance Supervisor in our exciting cGMP work environment. You'll lead the charge in ensuring excellence and innovation while having a blast along the way!
As the Quality Assurance Supervisor, you'll be the driving force behind our commitment to current Good Manufacturing Practices (cGMP) regulations in 21CFR 210, 211, Part 11 and in ICH Q7 . With your keen eye for detail and dynamic leadership skills, you'll inspire a team and foster a culture of quality and collaboration.
- Provide expert guidance in resolving complex quality issues, ensuring compliance with rigorous standards at the site
- Lead and inspire a high-performing team of 5-7 professionals, driving seamless release efforts and exceeding quality expectations
- Nurture a dynamic quality culture within the team, fostering continuous improvement and ensuring adherence to best practices
- Proactively monitor and analyze key performance indicators (KPIs) across departments and the site, implementing data-driven strategies for enhanced quality outcomes
- Strategically manage and prioritize weekly releases, optimizing efficiency while maintaining exceptional quality standards
- Take charge of critical investigations, meticulously conducting in-depth analyses of out-of-specification (OOS), out-of-trend (OOT), CAPAs, and Change Controls, and providing authoritative approval
- Actively participate in both internal and external audits, leveraging your expertise to ensure compliance with stringent regulations and industry standards
- 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
- Vigilantly monitor the production floor for any quality-related issues, taking prompt action and collaborating closely with stakeholders to swiftly resolve them
- Spearhead process improvement initiatives and projects, leveraging your expertise to drive continuous enhancement of quality-related practices, methods, and systems
Minimum Qualifications:
- Bachelor's Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science discipline
- 5 years industry experience
- 2 years of leadership or management experience
- Master's Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science discipline
- 2 years industry experience
- 2 years of leadership or management experience
- Knowledge/experience with ICHQ7 or API
- 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
Apply now and become a part of our diverse team!
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
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