Novartis · 1 day ago
Associate Coordinator Quality Control Mgmt
Durham, NC
Full-time
Onsite
Mid Level
4+ years expNovartis is a global healthcare company that is seeking an Associate Coordinator for Quality Control Sample to lead sample control support at their Durham, NC site. The role involves managing QC processes, ensuring compliance with GMP requirements, and improving sample management procedures.
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 for third party testing laboratories and manage testing turnaround times for testing metrics
Support new implementations of LIMs programs including updates and LIMs activities
Create/maintain change controls to ensure compliance with regulatory requirements and company/polices
Act as subject matter expert for sample management procedures
Author and review protocols, reports, investigations, non-conformance, CAPAs, and other records related to Quality control
Support Stability sets and pulls including aliquoting and shipping during the study
Qualification
Required
High School degree with 8 years related experience in a GMP Quality Control Laboratory or Associate's degree with 6 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 plus 4 years related experience in a GMP Quality Control Laboratory
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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