Bausch + Lomb Senior Quality Specialist in New Bedford, Massachusetts
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 nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 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.
Site administration and maintenance of the following Quality Systems:
Non-conformance/CAPA, Change Control, Document Management, Validation, training, labeling review, and complaints. Provides support regarding: investigations, supplier management, auditing, compilation of site quality/compliance metrics (including Management Reviews), and regulatory body inspections.
KEY ACTIVITIES/RESPONSIBILITIES :
Non-conformance/CAPA management activities include: Review of all site NC/CAPA issues to assure standardization of data entry, participation in root cause investigations and risk analysis, monitoring of issues to ensure timely and satisfactory closure, and trend analysis.
Document Management activities including: Initiation of Document Change Orders, maintenance of the document/SOP database, monitoring progress of documents through the creation/revision process, routine review and circulation of SOPs to ensure compliance with current practices.
Oversee site training program to ensure currency of employee training plans, development of training programs, and performance of GMP training. This position will also involve administration of electronic training system at the site.
Change Control Management including coordination and tracking of change control activities at the site.
Review labeling and artwork and update necessary BOMs and site documents affected by the change.
Review drawings and specifications, coordinate Production Part Approval testing at the site, create and modify receiving inspection instructions.
Assists in the compilation and trending of Site Quality/Compliance metrics and preparation of information for Management Reviews.
Site and Vendor Auditor.
Other duties as assigned to include: internal audits, preparation for and assistance during external audits, supplier management issues, and records retention.
Scope of position includes all Quality initiatives at the Lynchburg Distribution Center.
Working internal relationships include Site Operations, Inventory Control, and Maintenance, as well as relationships with Supplier Quality, Surgical Engineering, Global Packaging, Marketing, and Regulartory Affairs.
Bachelor's degree in Science or related field.
2-5 years' Distribution and/or Quality experience.
Strong analytical and computer skills to include common office software (i.e.MS Word, Excel, PowerPoint, and Outlook.
Strong communication skills.
Strong attention to detail.
This position may be available in the following location(s): [[location_obj]]
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.
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