Quality Control Sample Coordinator
~~~This role is offered through [MSP/supplier/third party provider], who, if selected, will be your employer. If your services are retained, you will be assigned to provide services to Novartis as the end client. This is not an offer of employment with Novartis. If you are selected for this Temporary/External opportunity, you will not be an employee of Novartis and will not be eligible for any Novartis employee benefits or incentives. ~~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!
Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com
Ready to work with/through Magnit at Novartis? Please read on...
Quality Control Sample Coordinator
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.
Requirements:
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 or Preferred, Bachelors’ degree in a relevant scientific concentration plus 2 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.
Location: Durham, NC(onsite)
Shift: Monday - Friday (7 AM - 4 PM or 8 AM - 5 PM)
Pay Rate: $27/hr - $30/hr W-2 Only (based on Education/Experience)
Contract: 7-month
Health, dental, vision, 401k (provided minimum eligibility hours are met)
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accommodation:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at [email protected].