Novartis
Senior Coordinator, Quality Control Sample
Novartis, Durham, North Carolina, United States, 27703
Senior Coordinator, Quality Control Sample
Apply for the
Senior Coordinator, Quality Control Sample
role at
Novartis .
Summary The Senior Coordinator leads sample control support at the assigned site/laboratory.
Location Durham, NC. This role is located on‑site; relocation support is not offered.
About The Role Key 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; understanding of FDA/EMEA regulations; effective interactions with Quality management; support investigations, inspections, and audits.
Manage sample tracking and inventory system for commercial and development samples.
Generate sample submission forms for testing facilities and process returned results.
Collect sample forecasts to ensure lead time notice.
Confirm testing completion when sample invoices arrive.
Follow and track international shipments and alert logistics group of customs clearance issues.
Inspect incoming sample shipments and take necessary action if samples do not comply with SOPs.
Review and evaluate temperature data reports from monitoring devices.
Execute protocols to support network stability, qualified material programs, and product studies.
Create and continuously improve sample management procedures and processes.
Communicate with other departments/sites including QA, Manufacturing, and Facilities to address compliance issues and implement corrective actions.
Write and revise documents such as SOPs and technical reports.
Support the Manager with training activities, task coordination, GMP compliance, and CAPA implementation.
Support stability sets and pulls, including aliquoting and shipping during studies.
Other related duties as assigned.
Essential Requirements
High School degree with 6 years of experience in a GMP Quality Control Laboratory OR Associate’s degree with 4 years of experience.
Preferred: Bachelor’s degree in a relevant scientific concentration with 2 years of experience.
Strong understanding of sample receipt and inventory management in a GMP laboratory.
Excellent oral and written communication skills with strong technical writing experience.
Ability to work independently and effectively within Quality and across the site.
Proficiency in both paper‑based and electronic laboratory information management systems.
Salary The salary for this position ranges between $32.10 and $59.61 per hour, with performance‑based cash incentives and eligibility for annual equity awards.
Benefits US‑based eligible employees receive a comprehensive benefits package including health, life and disability benefits, 401(k) with company match, and generous time off. Read more on our handbook.
Why Novartis Helping people with disease and their families requires innovative science and a community of smart, passionate people. Collaborate, support, and inspire each other to achieve breakthroughs that change patients’ lives.
EEO Statement Novartis is an equal opportunity employer and does not discriminate on any protected characteristic.
Accessibility & Reasonable Accommodations Contact Novartis Group of Companies by email at email@example.com or call +1(877)395-2339.
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Senior Coordinator, Quality Control Sample
role at
Novartis .
Summary The Senior Coordinator leads sample control support at the assigned site/laboratory.
Location Durham, NC. This role is located on‑site; relocation support is not offered.
About The Role Key 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; understanding of FDA/EMEA regulations; effective interactions with Quality management; support investigations, inspections, and audits.
Manage sample tracking and inventory system for commercial and development samples.
Generate sample submission forms for testing facilities and process returned results.
Collect sample forecasts to ensure lead time notice.
Confirm testing completion when sample invoices arrive.
Follow and track international shipments and alert logistics group of customs clearance issues.
Inspect incoming sample shipments and take necessary action if samples do not comply with SOPs.
Review and evaluate temperature data reports from monitoring devices.
Execute protocols to support network stability, qualified material programs, and product studies.
Create and continuously improve sample management procedures and processes.
Communicate with other departments/sites including QA, Manufacturing, and Facilities to address compliance issues and implement corrective actions.
Write and revise documents such as SOPs and technical reports.
Support the Manager with training activities, task coordination, GMP compliance, and CAPA implementation.
Support stability sets and pulls, including aliquoting and shipping during studies.
Other related duties as assigned.
Essential Requirements
High School degree with 6 years of experience in a GMP Quality Control Laboratory OR Associate’s degree with 4 years of experience.
Preferred: Bachelor’s degree in a relevant scientific concentration with 2 years of experience.
Strong understanding of sample receipt and inventory management in a GMP laboratory.
Excellent oral and written communication skills with strong technical writing experience.
Ability to work independently and effectively within Quality and across the site.
Proficiency in both paper‑based and electronic laboratory information management systems.
Salary The salary for this position ranges between $32.10 and $59.61 per hour, with performance‑based cash incentives and eligibility for annual equity awards.
Benefits US‑based eligible employees receive a comprehensive benefits package including health, life and disability benefits, 401(k) with company match, and generous time off. Read more on our handbook.
Why Novartis Helping people with disease and their families requires innovative science and a community of smart, passionate people. Collaborate, support, and inspire each other to achieve breakthroughs that change patients’ lives.
EEO Statement Novartis is an equal opportunity employer and does not discriminate on any protected characteristic.
Accessibility & Reasonable Accommodations Contact Novartis Group of Companies by email at email@example.com or call +1(877)395-2339.
#J-18808-Ljbffr