Associate Coordinator Quality Control Mgmt

Novartis•Durham, NC

1d•Onsite

About The Position

The Associate Coordinator, Quality Control Sample, leads sample control support at the assigned site/laboratory. Location: Durham, NC #LI-Onsite This role is located on-site in Durham, NC. Novartis is unable to offer relocation support for this role; please only apply if this location is accessible for you.

Requirements

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 OR Preferred, Bachelors’ degree plus 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.

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.