Quality Assurance & Compliance Specialist

Quality Assurance & Compliance Specialist

The Quality Compliance Specialist is responsible for ensuring that the organization's Quality Management System (QMS) is compliant with applicable regulatory requirements and site standards such as but not limited to (FDA, cGMP, ICH, etc.) and internal policies. This role supports internal and external audits, maintains compliance documentation, and drives continuous improvements related to inspections readiness initiatives. Responsible for various Quality System process improvements and Quality Assurance / System projects, which will require cross-functional work with support teams to develop and improve Quality Systems processes and Inspection Readiness.

Key Activities / Responsibilities :

• Quality Management System (QMS)
• Serve as a back up to for QMS elements such as Quality Change Control, Annual Product Reviews, Quality by Design initiatives and CoA / CoC creations.
• Prepare, review, and update Standard Operating Procedures (SOPs), as deemed required.
• Lead and participate in investigations stemming from QMS systems
• Audits & Inspections
• Coordinate and participate in internal audits.
• Support external inspections, including preparation of SMEs, audit logistics, and response development.
• Assist with tracking and facilitating closure of audit findings and observations.
• Continuous Improvement
• Identify compliance gaps and recommend corrective / preventive actions.
• Develop, track and use leading indicators to drive compliance and continuous improvement for site readiness
• Collaborate with cross functional teams to develop and ensure mature QMS systems
• General
• Complete assigned training by the assigned due date performs other duties as assigned.

Qualifications / Training :

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read Bausch + Lomb's Job Offer Fraud Statement. Our Benefit Programs : Employee Benefits : Bausch + Lomb Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.