Novartis · 1 day ago
Senior Coordinator, Quality Control Sample
Durham, NC
Full-time
Onsite
Mid, Senior Level
$67K/yr - $124K/yr
4+ years expNovartis is a leading pharmaceutical company, and they are seeking a Senior Coordinator for Quality Control Sample. This role involves leading sample control support, ensuring compliance with GMP requirements, and managing sample tracking and inventory systems.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Oversight of QC in-process, release, raw material, and stability, and development samples, associated document management, and collection of data
Adherence to all GMP requirements, a proficiency in understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations and inspections/audits
Manage sample tracking and the inventory system to track commercial and development samples
Generate sample submission forms for various testing facilities and process returned results
Collect sample forecasts to ensure lead time notice
Confirm testing was complete when sample invoices arrive
Follow/track international shipments, and alert logistics group of any customs clearance issues
Inspect incoming sample shipments and take necessary actions if samples do not comply with SOPs
Review and evaluate temperature data reports from temperature monitoring devices included with sample shipments
Execute protocols to support network stability, qualified material programs and pipeline product studies
Create and continuously improve sample management procedures and processes
Communicate with other departments and sites including Quality Assurance, Manufacturing and Facilities to address compliance issues and to implement corrective actions and to improve programs
Write and revise documents such as SOPs and technical reports
May support the Manager for activities related to training of employees, coordination of tasks, compliance with GMP, and identifying and implementing corrective and preventive actions
Support Stability sets and pulls including aliquoting and shipping during the study
Other related job duties as assigned
Qualification
Required
High School degree with 6 years related experience in a GMP Quality Control Laboratory or Associate's degree with 4 years related experience in a GMP Quality Control Laboratory
Possess a strong understanding of the requirements of sample receipt and inventory management in a GMP laboratory
Excellent oral and written communication skills with strong technical writing experience required
Able to work independently and effectively within the group, within Quality, and across the site
Ability to work in both paper based and electronic laboratory information management systems
Preferred
Bachelors' degree in a relevant scientific concentration plus 2 years related experience in a GMP Quality Control Laboratory
Benefits
Health, life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-01-07
2026-01-07
2026-01-03
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