LTS is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems for the pharmaceutical industry.
LTS´ commercial offering encompasses more than 20 marketed products.
LTS operates today from 5 sites: Netanya (Israel), Adrenarche (Germany), West Caldwell (NJ, USA), St. Paul (MN, USA), and Shanghai (China).
We are looking for an excellent QA Supplier and Operations Engineer to join our team in Israel.
The position is permanent, full time, hybrid.
עיקרי התפקיד
Support supplier qualification, monitoring, documentation review, quality agreements, and supplier change notifications.
Assist with supplier-related non-conformances and SCARs, including follow-up of investigations, corrective actions, closure, and effectiveness evidence.
Support supplier audit activities, including preparation, documentation of findings, supplier response follow-up, and action tracking.
Assist with component and supplier qualification activities, including documentation collection, quality review, and cross-functional coordination.
Provide QA support for GMP manufacturing activities, including production quality events, deviations, NCMRs, and quality documentation review.
Support cleanroom quality activities, including environmental monitoring follow-up, contamination control, excursions, microbial sampling, and related documentation.
Review SOPs, protocols, reports, GMP records, ECOs, supplier documents, deviations, and validation-related documents under guidance.
Assist with ECOs, supplier changes, and process change assessments, including documentation review and implementation follow-up.
Collect and summarize supplier and QA operational quality data, including supplier performance, SCARs, audit findings, NCMRs, cleanroom excursions, and EM trends.
Support continuous improvement activities related to supplier management, investigations, documentation practices, and cleanroom/production quality processes.
Support internal, customer, regulatory, and supplier audits by preparing objective evidence and tracking audit-related actions.
Perform activities in accordance with GMP, ISO 13485, applicable regulatory requirements, LTS procedures, quality agreements, and customer requirements.
Direct Manager: QA suppliers and NC Team Leader
דרישות
Education:
BSc in Life Sciences, Biotechnology, Biomedical Engineering, Quality Engineering, Industrial Engineering, or similar – must.
Job skills:
0-2 years of relevant experience in supplier quality, QA operations, quality engineering, production quality support, or GMP manufacturing support in a medical device, pharmaceutical, or biotech environment – must.
Previous experience in the medical device or pharmaceutical industry – must.
Experience with quality documentation review, ECO support, GMP records, SOPs, protocols, reports, validation-related documentation, supplier documentation, and audit evidence preparation.
Ability to conduct effective root cause investigations and critically assess corrective action strategies, implementation evidence, and effectiveness as applied to both internal quality events and supplier-related SCARs.
Strong analytical ability, attention to detail, audit-readiness mindset, and ability to prioritize topics with potential quality, compliance, production, or customer impact.
Ability to work independently while collaborating effectively with cross-functional interfaces and external suppliers.
Computer skills:
Full proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, Outlook, and Microsoft Project.
Language skills:
High-level English writing and verbal communication skills – must.
Personality:
At LTS, we value collaboration, innovation, and accountability.
We're looking for individuals who can:
Teamwork: Collaborate effectively, embracing diverse perspectives.
Customer Focus: Exceed internal and external customer needs.
Innovation: Create new opportunities with enthusiasm.
Accountability: Take ownership of challenges, uphold standards.
Leadership: Motivate and develop talents, achieving goals.
יתרון
CMQ / CQE / CQA / ASQ certification, Six Sigma certification, or relevant quality/auditor certification
Experience with NC/NCMR handling, deviation investigations, root cause analysis, CAPA follow-up, and effectiveness verification – strong
Good understanding of GMP and quality system principles. Knowledge of ISO 13485, ISO 9001, FDA QMSR/21 CFR Part 820, and applicable international standards
Experience with SAP, QMS/eQMS systems, electronic documentation systems, or supplier management systems