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 aa 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:

　　Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.

　　Ensures that the quality assurance programs and policies are maintained and modified regularly.

　　Coordinate Document Control, Record Management, Training and Change Management support functions.

　　Responsiblities:

　　Administration of the Document Control System - Maintains number system for all QSR specific files (procedures, specifications, drawings, artwork, labels, validations, audits, etc.). Controls circulation of DCR routing and approval process in Clearwater. Administrator of the DCR log database.

　　Processes Document Change Requests. Reviews all Document Change Requests submitted for complete information/approvals/supporting documentation and document format. Generates procedures, specifications, and forms.

　　Coordinates the monthly Document Review meeting - compiles list of documents that have not been updated in the past 3 years, sets up meeting, tracks completion of assignments and document updates or removals.

　　Evaluates and enhances current processes in document related areas for improved efficiency, automation, and improved productivity.

　　Trains new department employees (DCR System, GDMS System, cGMP training, etc.)

　　Maintains local IHS contact for new/revised standards; maintain standards cabinet and onsite certifications from notified bodies.

　　Misc. - Record Retention Coordinator (document archiving, retrieval of documents from offsite storage, record storage administration and maintenance (Iron Mountain off-site & local on-site storage). Maintains on-site, off-site and destroy lists of all Quality/Non-Quality records. Orders boxes electronically from Iron Mountain as needed, files records and boxes individually. Maintains all process records for manufacturing retention documents.

　　TMSWeb Administrator - Maintains and coordinates TMS Web training. Enters training results, add new employees to TMS Web along with their training assignments, inactivate employees from TMS Web upon termination. Generate training reports for department personnel to ensure acceptable levels of training completion.

　　Acts as Lead Documentum (GDMS) Coordinator, providing training and problem resolution for local & global users. Processes Global Documents & DCOs, maintains CLW cabinets, processes Global Deviations/Variances, and participates in monthly meetings for GDMS. Provides monthly GDMS Procedure Notifications to Supervisors and Staff.

　　Training Department Administrator - Maintain training within TMSWeb and hard-copy files. Assign training for new permanent employees and temporary employees. TMSWeb department manager for Quality departments.

　　Performs and documents internal audits. Runner/Reviewer for audits.

　　Performs Change Control Specialist function for the site as part of the Change Management process.

　　Requirements :

　　Associate Degree.

　　Minimum 3 years quality experience.

　　Minimum 2 years experience in Medical Device and/or Pharmaceutical Industry.

　　Preferred Qualifications:

　　Bachelor's Degree.

　　Working knowledge of 21 CFR 820, ISO 13485, Quality tools, problem solving tools, and statistical techniques and application experience.

　　Lead Auditor.

　　We offer competitive salary & excellent benefits including:

　　Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date

　　401K Plan with company match and ongoing company contribution

　　Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time

　　Employee Stock Purchase Plan with company match

　　Employee Incentive Bonus

　　Tuition Reimbursement (select degrees)

　　Ongoing performance feedback and annual compensation review

　　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 (https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx) .

　　Our Benefit Programs: https://www.bausch.com/careers/benefits/

　　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.