Process Engineer II

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 Job:  

Document Control - Supervise staff that provides documentation support to all areas of the plant for SOP's, specifications, and batch records.  Support the efforts of the company for conversion to electronic document processing and control. 

Compliance - Responsible for the continuous development and maintenance of the compliance status of the activities of the Bausch + Lomb Tampa Pharmaceuticals Organization. Mentor, coordinate and manage compliance team to ensure that site regulatory compliance requirements are met.

Key Activities/Responsibilities:

1. Supervise staff in connection with all phases of document processing.
2. Provide documentation review and support for new records/forms, SOP's and for document revision.
3. Lead Documentation representative in Tampa for support activities and updates to electronic document handling systems.        
4. Primary for tracking and trending reports to monitor compliance for all departments' document control activities. (e.g., Periodic reviews of documents, acknowledgements of receipts in timely manner, quantity of document changes and timing).
5. Responsible for coordination requests to documentation systems.
6. Responsible for the coordination of special documentation request for other B & L facilities or local departments.  Support audits (regulatory and contract business).
7. Responsible for the storage and retrieval of existing and historical copies of controlled documentation for Tampa facility.

8. Provide expertise and guidance to the entire facility, including management, in interpreting the statutory regulations/guidelines (i.e. FDA) internal procedures (SOPs, forms etc.) and Valeant Regional procedures to ensure compliance.

9. Coordination of preparation and execution of inspections by regulatory agencies, consultants and third parties.

10. Provide leadership as a team member and as a liaison between the facility and external auditing bodies, including, but not limited to, Corporate, Regulatory bodies, Health Authorities etc.  This includes preparing the facility for the audit, performing gap assessment, assisting in the audit as well as trending and tracking of any regulatory audit findings. 

11. Executes an internal audit plan, including the pre-audit meeting, perform the audit and post-audit meeting using generally accepted auditing techniques and tools as well as the team concept, which utilizes personal interaction skills.  Assure completion of audit plan to ensure facility compliance and readiness for regulatory and corporate audits. 

Qualifications/Training: 

• Minimum of BA/BS (science major preferred)
• Supervisory leadership and training experience
• High level of competency of MS office applications such as MS Word, Excel, and Access.
• 12+ years of experience in Compliance & Document Control.
• Experience with electronic documentation systems and methods.
• Must be able to read, write, and speak English and possess basic.

This position may be available in the following location(s): US - Tampa, FL

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.

Our Benefit Programs: Employee Benefits: Bausch + Lomb

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.

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