Quality assurance systems lead

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objectives / Purpose of the Job

Provide quality support to all manufacturing processes. Partner with Operations, Maintenance and other support functions to resolve issues on shift, contain non-conforming product, and ensure appropriate disposition and documentation. Oversee product and process performance using appropriate shift metrics. Conduct auditing activities to determine compliance and identify improvement opportunities. Support continuous improvement and corrective actions. Complete additional requirements specified by the Quality Engineering Manager.

Key Activities / Responsibilities

• Coordinate containment of non-conforming product and material as required.
• Assist with quality-related product and material disposition decisions on the manufacturing floor.
• Make appropriate product-disposition and quality decisions on a shift-by-shift basis.
• Lead investigations into floor quality issues to determine root cause and corrective actions.
• Assist with initiation and processing of Non-Conformance Reports (NCRs).
• Perform data analysis and trending.
• Support complaint management and investigation when required.
• Independently review records as required.
• Support process and Quality System improvement.
• Initiate CAPA where relevant.
• Ensure process audits are completed as required.
• Escalate quality-related issues to Quality Engineering as necessary.
• Complete other QA duties, including project support.
• Follow Standard Operating Procedures at all times.
• Maintain awareness of applicable standards and QMS requirements.
• Follow gowning procedures and entry rules for manufacturing and controlled areas.
• Follow Personal Hygiene Rules defined in the GMP Training Programme and notify supervision of health conditions that may affect product quality.
• Maintain a clean and tidy work area.

Supervise Direct Reports

No

Scope of Position

The QA Shift Lead supports the manufacturing process in dealing with quality-related issues while ensuring compliance with applicable quality standards and GMP requirements.

Key Relationships

• Production colleagues
• Production managers
• Maintenance technicians
• Warehouse colleagues
• Process Excellence Department
• Training Department
• QA Department
• Engineering Department
• HR Department
• IT Department

Qualifications / Training

• Working knowledge of Microsoft Office products; ECDL qualification desirable.
• Familiarity with Documentum or similar documentation systems is desirable.
• Working knowledge of CAMS and CATSweb.
• Understanding of existing quality and manufacturing systems and procedures.
• Strong verbal and written communication skills.
• Excellent numerical skills.
• Decisive, self-motivated, capable of working on own initiative, able to prioritise and proactive.
• High attention to detail.
• Database-management experience is an advantage.
• Experience in a medical-device or pharmaceutical environment.
• Knowledge of cGMP, documentation control and computer systems.

Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.