Supervisor, Senior Quality Assurance

Bausch + Lomb•US-SC-Greenville, SC

11h•Onsite

About The Position

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. Purpose of Job: The role of Senior Manufacturing Quality Assurance (MQA) Supervisor is integral to the on-going compliance of the manufacturing and distribution processes. The MQA Supervisor is involved in the following stages of the product life cycle --- manufacturing support, and post-launch maintenance.

Requirements

Four-year college degree (BA/BS) in fields such as life, physical sciences, or engineering
5 years' experience in a QA role within an FDA regulated manufacturing or distribution facility required.
Supervisory experience required either in a quality compliance role or an operations/manufacturing role.
Must have experience in incoming and/or finished product inspection experience with use of sampling plans preferred.
Should have experience with computerized inventory and warehouse systems.
Experience in leading, conducting and writing investigations

Nice To Haves

Specialized training in 21CFR211, 21CFR820, ISO 9001:2000, ISO 13485 preferred.
Certifications preferred: CQA, CQE, CQM.
Should have experience in a contract manufacturing and/or Distribution Operations arena.
Experience as an internal or external auditor and in conducting investigations is a definite plus.
Should have experience with automated quality documentation systems (e.g. Track Wise, Assurx, Change Control).

Responsibilities

Supervise the MQA Product Release and MQA Line Inspection groups.
Review, revise and approve procedures and specifications as needed.
Communicates and implements the document/process changes with the department and operations.
Identify, evaluate, select, and against continuous improvement and compliance initiatives.
Monitor daily operation activities to ensure compliance to applicable CFRs, ISO Requirements, and applicable local and global quality system requirements.
Write, track and manage performance evaluations, and help to manage the performance of department staff.
Establish, manage and monitor departmental budget and spending against stated variances.
Promote open communications with the department and internal customers.
Interview, hire and support a qualified and diverse department staff.
Institute/Maintain training programs to develop staff.
Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
Supports/leads investigations using root cause analysis tools and proposing/implementing systemic corrective actions.
Implements corrective action efforts associated with Product Release and Inspection activities.
Ensures solutions and contract manufacturing lots that do not conform to quality standards are fully investigated within the pre-established turn-around timeframe.
Provides routine analysis of performance indicators.
Presents this information to management, supervisors, and manufacturing operators.