Associate Coordinator Quality Control Mgmt

Band

Job Description Summary

Job Description

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 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.

Requirements:

• High School degree with 8 years related experience in a GMP Quality Control Laboratory or Associates 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.

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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an e-mail to call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

Skills Desired