Quality Assurance Specialist I
Date: Sep 19, 2023
Location: US-SC-Greenville, South Carolina, US
Company: Bausch & Lomb
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.
Purpose:
The Quality Specialist shall work independently to perform and/or manage site administration, support and maintenance of the following Quality Systems:
Non-conformance/CAPA, Change Management, Document Management, Records Management, Training and product release. Additional support/oversight regarding product/process investigations, Supplier Management, internal/corporate/external audit support, process/continuous improvement, compilation of site quality/compliance metrics, including Management Reviews.
Key Activities:
- Warehouse management system release of CMO products including: Transportation document review, QA release document review, quantity reconciliation and product stability (transportation temperature).
- Perform product holds, change product status and support CAC/Recall investigations, as needed.
- Coordinate product impact assessments, warehouse investigations and technical support for third party logistics centers.
- Liaise between GDC Quality, contract manufacturing Quality and Supply Chain. System releases may occur across multiple business units, if necessary.
- Provide Quality support to Inventory Control, when necessary. Provide Quality technical support to evaluate/approve damaged, aged or expired product for destruction, both internally and with third party logistics centers.
- Change Management activities including: Change control review, change control metric reporting, site Change Review Specialist and tracking/reporting change control progression.
- Document Management activities including: Initiation of document Change Requests (CRs), tracking CRs through the D2 workflow, reporting of document control metrics, support document authors, as necessary and support the “To Be Reviewed” (TBR) process. Attend site Document Coordinator corporate meetings.
- Back up the site Records Management Coordinator with regard to on-site/off-site records archiving. Including: maintenance of records archiving log, assist record owners with the archiving process, off-site records requests, as needed.
- Assist in the compilation and trending of site Quality Metrics (QPI) and Value Preservation metrics. Preparation of data for Management Review.
- Other duties may include internal/corporate/external audit support, Supplier Management support, training, process improvement activities, GMP/GDP.
Qualifications:
- Bachelors BS/BA Degree preferred
- 3+ years’ experience in a GMP environment.
- 3+ years Distribution and/or Quality experience preferred.
- Strong analytical and computer skills to include common office software (Word, Excel, PowerPoint), warehouse management systems/inventory systems.
- Strong communication skills and strong attention to detail.
This position may be available in the following location(s): US - Woodruff, SC (Distrib)
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: 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.
#LI-CA1