Compliance Specialist - Tampa, United States - Bausch + Lomb

Bausch + Lomb

Verified Company

Tampa, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

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:

Responsible for overseeing compliance to International and Regional Quality change management requirements; managing life cycle of all site Quality Change Requests (QCRs); review of QCRs for completeness and accuracy; coaching of requestors through the change control process and resolution of deficiencies with the requests; facilitating impact assessment of the QCRs; manages routine Local Change Board (LCB) meetings; dispositioning QCRs on behalf of the LCB.

Key Activities/Responsibilities:

Change Review Specialist (CRS): reviews most QCRs for completeness and accuracy. (information is factual and objective without opinions, conjecture or exaggeration)

Works closely with the requestor of the QCR to develop and refine the information in the request.

Liaises with functional groups (Regulatory Affairs, R&D, and Mfg) to assess the potential impact of the change on existing processes and products and the strategy for implementation of the change.

Manages local change board (LCB) review and approval/rejection of all QCRs.

Determines per NSOP guidance if QCRs should be elevated to Change Oversight Committee (COC) and, if elevated, coordinates with Maintenance of Business (MOB) coordinator and requestors to present changes to the COC.

Determines if other sites are impacted and assures impacted sites are notified of the change.

Performs approval of change requests on behalf of the LCB and monitors status of QCRs throughout the workflow steps.

Helps to develop and implement change control and other QA system improvements. Assists in overseeing the compendial review processes.

Qualifications/Training:

BA or BS in any interdisciplinary science or engineering field.

NLT 2 years in a GMP facility. Equivalent education and experience considered.

Proficiency in computer operation; ability to work independently and efficiently; good organizational and investigational skills; ability to follow detailed written procedures; able to handle multiple tasks simultaneously and prioritize; accordingly, good communication skills, verbal and written; good analytical ability; ability to work well with others;
Good problem-solving skills; detailed-oriented.

Must be able to read, write, and speak English and possess basic math skills.

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.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

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.