Quality Assurance Manager

The Opportunity:

Avantor is looking for a steadfast and analytical Quality Assurance Manager to champion our Quality Control & Assurance team, and deliver continuous compliance for Avantor’s Buford, Georgia site.

This role will be a full-time position based out of our Buford, Georgia facility with 5% domestic and international travel (as needed). You will have the opportunity to partner with stakeholders and customers, influence and guide internal associates, and cross-collaborate with leaders at Avantor’s domestic and international facilities. If you have experience in Quality Control and Quality Assurance and are passionate about people leading – let’s talk!

The team

Avantor’s Quality Control & Assurance team is part of our Global Services Quality business unit. This team supports the quality systems and compliant readiness for the Buford, Georgia site by upholding Quality Assurance (QA) and Quality Control (QC) programs in addition to all applicable certified regulations and standards.

What we’re looking for

• Education: Associate’s Degree or equivalent education is required

• Experience: 6 – 8+ years of related Quality experience required

  • 1 – 3+ years of people management experience required

• Collaboration Tool: Microsoft Teams experience preferred

• Preferred Qualifications:

  • Bachelor’s Degree in a related field

  • Bilingual in Spanish

  • Experience working in a regulated industry (medical devices, API, pharmaceuticals, etc.)

  • Functional knowledge of Microsoft Outlook, Word, and Excel (or equivalent)

  • Previous exposure and experience with automated inventory control systems

How you will thrive and create an impact

• Lead all aspects of and ensure Quality Assurance program, Quality Assurance leadership and associates.

• Direct CAPA program and support Lead Auditor to ensure CAPA and audit programs (internal and external) are sound.

• Close or raise complaints / CAPA inputs.

• Attend to and guide inspections as required.

• Oversee systems that effect quality of product.

• Be responsible for product recalls.

• Maintain the integration of FDA regulations and ISO standards into the Quality Management System (QMS).

• Direct implementation, conduct audits, and oversee application of business Quality Management System (ISO/QSR).

• Lead customer audits, including audit preparation, documentation, follow-up, and closure.

• Support supplier evaluation program, including supplier audit program. Review program and advise Purchasing where issues exist.

• Provide technical support regarding the revision or implementation of process documentation, including procedures, work instructions, and forms.

• Solid understanding of and support compliance with ISO 9001, ISO 13485 and FDA Quality System Regulations (QSR).

• Evaluate and advise management on current, new or proposed regulations and standards changes. Provide enterprise-wide strategic insight to senior management.

• Support and advise vital continuous improvement projects as a result of periodic trend reporting including but not limited to; management review; complaint investigation; supplier, customer, and internal audits; and any other relevant quality event.

• Use Six Sigma and Lean Manufacturing methodology to drive quality system improvements.

• Build, implement, and maintain process improvements, key initiatives, projects, and tasks, as assigned.

• Coordinate and support ETQ Reliance Software based on Global Compliance Direction.

• Deploy effective root cause analysis enterprise-wide.

• Prepare, conduct, and offer necessary recommendation training on quality assurance concepts and tools, as requested.

• Consult with Sales on viability and capabilities of new products including; understand product workflow from start to finish, review design process and ensure finished good(s) meets written expectations/specifications as it relates to customer specifications.

• Lead Complaint Investigation efforts, including managing weekly meetings and reviewing prior to closure.

• Conduct periodic review of complaint process, audit program, and related quality programs.

• Support validation program.

• Performs other duties as assigned.

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

Works in an administrative area thermostatically controlled to room temperature with adequate lighting and ventilation.

May work a portion of the day on the production floo