Quality Assurance Supervisor Job at Merck Group, Milwaukee, WI

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  • Merck Group
  • Milwaukee, WI

Job Description

Job Description

Work Location: Milwaukee, Wisconsin
Shift:
Department: LS-SC-PMSQMA Milwaukee QA
Recruiter: Michelle Cole

This information is for internals only. Please do not share outside of the organization.

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:

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

Minimum Qualifications:

  • Bachelor's Degree in any discipline
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OR
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  • High School Diploma or GED
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  • 4+ years of Quality Assurance experience
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Preferred Qualifications:

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  • Proven leadership ability complemented by strong negotiation and client-facing communication skills
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  • Expertise in Quality System regulations, including 21 CFR (Parts 820, 211, 600), ICH Q7, ISO standards, and Good Distribution Practices (GDP)
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  • Strong understanding of current processing requirements for both drug and biologic products
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  • Proficiency in the principles and application of process, cleaning, and equipment validation
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  • Demonstrated expertise in managing and conducting quality system audits
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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.

Job Tags

Local area, Immediate start, Shift work,

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