Synergetics
Senior Quality Specialist, Supply Chain
Synergetics, Woodruff, South Carolina, United States, 29388
Senior Quality Specialist, Supply Chain – Synergetics
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Senior Quality Specialist, Supply Chain
role at
Synergetics .
Purpose of Job Supports the maintenance of the site Quality Systems to assure compliance with applicable regulatory requirements, standards and Bausch + Lomb QMS requirements. Management of various Logistic Providers globally inclusive of 3PLs (re-packagers /re-labelers), distributors, and transportation providers to ensure consistent delivery of goods and services to meet quality standards using a proactive and collaborative approach with various stakeholders.
Key Activities
Support the development, implementation and maintenance of efficient, effective and compliant quality systems at the distribution level supporting product record reviews/system release.
Release of product for distribution across business units, Non-conformance/CAPA management, Change Management, Document Management, Records Management, Data Integrity, Risk Management and Training.
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.
Provide Quality support to Inventory Control, when necessary as well as evaluate/approve damaged, aged or expired product for destruction, both internally and with third party logistics centers.
Develop, implement, and maintain global logistics standards across Supply Chain Quality (storage & transportation, to include global guidance on managing shipping lanes and temperature excursions during transport, etc.).
Develop, implement, and maintain supplier management in company systems (Catsweb) for these type suppliers.
Arrange & conduct 3PLs, distributor and transportation supplier qualifications.
Create, update, and maintain Quality agreements.
Manage Supplier Audit Program for 3PLs, datalogger, and transport providers.
Ensure Good Distribution Practices (GDP), temperature controls, results, and traceability requirements are established and monitored.
Provide supplier performance results & escalate issue to management, when appropriate.
Propose solutions with action plans to resolve, when appropriate.
Manage and/or participate in projects to continuously improve logistics (storage and transport).
Active member of Global Distribution QMS team.
Qualifications
Bachelor’s degree in science or related field.
Minimum 5 years’ experience in Quality in an FDA regulated industry.
Minimum of 3 years Distribution center/logistics experience, inclusive of processes & electronic systems for distribution and inventory management.
ASQ Certification (e.g., CQA, CQE) desirable/ ISO Certified Lead auditor desirable.
Strong analytical & computer skills to include Windows, Word, Excel, PowerPoint, etc.
All qualified applicants will receive consideration 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.
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Senior Quality Specialist, Supply Chain
role at
Synergetics .
Purpose of Job Supports the maintenance of the site Quality Systems to assure compliance with applicable regulatory requirements, standards and Bausch + Lomb QMS requirements. Management of various Logistic Providers globally inclusive of 3PLs (re-packagers /re-labelers), distributors, and transportation providers to ensure consistent delivery of goods and services to meet quality standards using a proactive and collaborative approach with various stakeholders.
Key Activities
Support the development, implementation and maintenance of efficient, effective and compliant quality systems at the distribution level supporting product record reviews/system release.
Release of product for distribution across business units, Non-conformance/CAPA management, Change Management, Document Management, Records Management, Data Integrity, Risk Management and Training.
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.
Provide Quality support to Inventory Control, when necessary as well as evaluate/approve damaged, aged or expired product for destruction, both internally and with third party logistics centers.
Develop, implement, and maintain global logistics standards across Supply Chain Quality (storage & transportation, to include global guidance on managing shipping lanes and temperature excursions during transport, etc.).
Develop, implement, and maintain supplier management in company systems (Catsweb) for these type suppliers.
Arrange & conduct 3PLs, distributor and transportation supplier qualifications.
Create, update, and maintain Quality agreements.
Manage Supplier Audit Program for 3PLs, datalogger, and transport providers.
Ensure Good Distribution Practices (GDP), temperature controls, results, and traceability requirements are established and monitored.
Provide supplier performance results & escalate issue to management, when appropriate.
Propose solutions with action plans to resolve, when appropriate.
Manage and/or participate in projects to continuously improve logistics (storage and transport).
Active member of Global Distribution QMS team.
Qualifications
Bachelor’s degree in science or related field.
Minimum 5 years’ experience in Quality in an FDA regulated industry.
Minimum of 3 years Distribution center/logistics experience, inclusive of processes & electronic systems for distribution and inventory management.
ASQ Certification (e.g., CQA, CQE) desirable/ ISO Certified Lead auditor desirable.
Strong analytical & computer skills to include Windows, Word, Excel, PowerPoint, etc.
All qualified applicants will receive consideration 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.
#J-18808-Ljbffr