Quality Compliance Documentation Specialist
Synergetics
Date: 20 hours ago
City: Greenville, SC
Contract type: Full time
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 Documentation Specialist is responsible for processing all Greenville documents and for the oversight and management of the document control program.
This position is the site administrator for the document management electronic system (D2-GDMS) and ensures content of site documents meet regulatory and QMS requirements.
This position is also responsible for the records management process and coordinates the document retention and destruction process. The QA Documentation Analyst is the site document management and records management representative on global initiatives.
This position will also routinely provide administrative support for External audits (FDA, ISO, Global, etc.) when needed.
Key Activities
Qualifications:
Minimum AS degree required and BS degree is preferred. Equivalent experience may be recognized.
Experience
This position may be available in the following location(s): US - Greenville, SC (Plant)
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.
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 Documentation Specialist is responsible for processing all Greenville documents and for the oversight and management of the document control program.
This position is the site administrator for the document management electronic system (D2-GDMS) and ensures content of site documents meet regulatory and QMS requirements.
This position is also responsible for the records management process and coordinates the document retention and destruction process. The QA Documentation Analyst is the site document management and records management representative on global initiatives.
This position will also routinely provide administrative support for External audits (FDA, ISO, Global, etc.) when needed.
Key Activities
- Process Greenville documents in GDMS to include reviewing, routing, promotion of effective documents, copying and distributing copies.
- Maintain the Annual SOP Review Process, which includes sending monthly notifications of SOPs to be reviewed, issuing periodic SOP status reminders and completing monthly reports.
- Manages process for review of global document updates to ensure local changes are made as necessary to maintain compliance with the global Quality Management System.
- Provide administrative support for external audits and as needed for the Quality Systems group.
- Coordinates the record retention and destruction process.
- Site administrator for electronic document management system.
- Reviews document content and edits as necessary to ensure compliance.
- Additional activities to support Quality System Compliance Department as needed.
Qualifications:
Minimum AS degree required and BS degree is preferred. Equivalent experience may be recognized.
Experience
- Minimum of 3 years of prior office and/or computer (Microsoft Office) experience required.
- Minimum of 2 years experience in a GMP regulated environment is required.
- Well organized with the ability to multi-task and shift priorities as needed to meet customer demands.
- Demonstrated proficiency in Microsoft Office to include use of Excel spreadsheets, Microsoft Word, and ACCESS database. Knowledge and experience with an electronic document management system.
This position may be available in the following location(s): US - Greenville, SC (Plant)
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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