Senior Quality Assurance Specialist – Global Compliance & CAPA

Bausch & Lomb GmbH; Lynchburg (VA); Vor Ort; USD 86.000 - 130.000; Vollzeit

Zusammenfassung

Bausch + Lomb is seeking a Senior Quality Specialist to develop and maintain site Quality systems ensuring FDA, ISO, and country-specific compliance, and alignment with Bausch + Lomb QMS requirements. You will support local and global quality initiatives and collaborate with site functions to ensure regulatory compliance.

The role involves leading continuous quality improvement projects, coordinating internal audits, and directing corrective actions.

Qualifikationen

• Bachelor's degree in Science or related field.
• Minimum 5 years experience in Quality in an FDA regulated industry.
• ASQ certification (CQA, CQE, and/or SSBB) desirable.
• Experience with logistics systems for inventory control and distribution a plus.
• Strong analytical and computer skills to include Windows, Word, Excel, Power Point, etc.

Aufgaben

• Nonconformance/CAPA, Change Control, Document Management, Records Management, Data Integrity, Validation, Risk Management, Training, Regulated Labeling Maintenance reviews, Customer Complaints, Supplier Management, Auditing (internal/supplier).
• Compilation of site quality/compliance metrics to support Management Oversight inputs.
• Quality system support for logistics centers as requested.
• Development, implementation, and maintenance of quality system at distribution level supporting product record reviews/system release.
• Systematic control of non-conforming material and corrections/removals where applicable.
• Coordinate activities of various functional areas for critical quality issues.
• Keep senior management updated on compliance issues and propose action plans.
• Lead cross-functional teams to drive compliance and quality improvements.
• Support external audits as assigned.
• Provide direction using continuous quality improvement principles.
• Identify systemic weaknesses and lead corrective actions; perform root cause analysis.

Kenntnisse

Quality assurance

Analytical skills

Windows/Office

FDA regulations

Ausbildung

Bachelor's degree in Science

ASQ certification (CQA, CQE, SSBB) desirable

Tools

Logistics software

Jobbeschreibung

Bausch + Lomb is seeking a Senior Quality Specialist to develop and maintain site Quality systems ensuring FDA, ISO, and country-specific compliance, and alignment with Bausch + Lomb QMS requirements. You will support local and global quality initiatives and collaborate with site functions to ensure regulatory compliance.

The role involves leading continuous quality improvement projects, coordinating internal audits, and directing corrective actions.