Quality Assurance Supervisor at Merck KGaA
Milwaukee, WI 53209, USA -
Full Time


Start Date

Immediate

Expiry Date

26 Nov, 25

Salary

0.0

Posted On

26 Aug, 25

Experience

4 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Communication Skills, Iso Standards

Industry

Human Resources/HR

Description

Job Id
290357
Milwaukee, Wisconsin, United States
Job Type
Full-time
Work Your Magic with us! Start your next chapter and join MilliporeSigma.
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

The Quality Assurance Supervisor will lead, train, and mentor the QA team, managing performance to meet department goals. Additional responsibilities include the following:

  • Supervise daily team activities to ensure quality, productivity, and safety
  • Collaborate with leadership on team development and retention strategies
  • Serve as the primary site representative for Quality Assurance
  • Resolve complex or unusual customer quality issues
  • Implement, maintain, and continuously improve the QMS to ensure compliance with ISO 9001, GDP, and GMP standards
  • Drive the identification and implementation of system and process improvements
  • Direct the management of Change Control, CAPA (Corrective and Preventive Action), and Deviation programs
  • Lead Supplier Quality initiatives, internal/external audits, and Quality Risk Management
  • Manage the company’s Training program and Document Control system to ensure compliance
  • Oversee the full lifecycle of customer complaints and the recall management process
  • Assist in overseeing QMS and Good Distribution Practice (GDP) in the Distribution Center
  • Ensure the team’s work quality and timeliness support cross-functional needs
  • Manage the team’s daily workflow while handling more complex QA tasks

Who You Are

Minimum Qualifications:

  • Bachelor’s Degree in any discipline

    OR

  • High School Diploma or GED

  • 4+ years of Quality Assurance experience

Preferred Qualifications:

  • Proven leadership ability complemented by strong negotiation and client-facing communication skills
  • Expertise in Quality System regulations, including 21 CFR (Parts 820, 211, 600), ICH Q7, ISO standards, and Good Distribution Practices (GDP)
  • Strong understanding of current processing requirements for both drug and biologic products
  • Proficiency in the principles and application of process, cleaning, and equipment validation
  • Demonstrated expertise in managing and conducting quality system audits
Responsibilities
  • Supervise daily team activities to ensure quality, productivity, and safety
  • Collaborate with leadership on team development and retention strategies
  • Serve as the primary site representative for Quality Assurance
  • Resolve complex or unusual customer quality issues
  • Implement, maintain, and continuously improve the QMS to ensure compliance with ISO 9001, GDP, and GMP standards
  • Drive the identification and implementation of system and process improvements
  • Direct the management of Change Control, CAPA (Corrective and Preventive Action), and Deviation programs
  • Lead Supplier Quality initiatives, internal/external audits, and Quality Risk Management
  • Manage the company’s Training program and Document Control system to ensure compliance
  • Oversee the full lifecycle of customer complaints and the recall management process
  • Assist in overseeing QMS and Good Distribution Practice (GDP) in the Distribution Center
  • Ensure the team’s work quality and timeliness support cross-functional needs
  • Manage the team’s daily workflow while handling more complex QA task
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