Summary
The Coordinator, Quality Control Sample, provides sample control support at a Manufacturing facility.
Job Description
Responsibilities:
Create sample tracking and inventory system to track development samples
Administration of QC in-process, release, and stability samples, associated document coordination, and collection of data. Additional responsibilities include adherence to all GMP requirements, a basic understanding of FDA/EMEA regulations, effective interactions/communication with Quality management, personal development, and support of investigations.
May support the Manager for activities related to training of employees, compliance with GMP, and identifying and implementing corrective and preventive actions.
Generate sample submission forms for various testing facilities
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
Create equipment, inventory, and sample receipt and tracking logbooks
Draft sample management procedures
Communicate with other departments 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.
Other related duties as assigned.
Requirements:
Associates Degree in scientific field and 2 years of related experience in a GMP Quality Control laboratory., B.A. or B.S. in microbiology or related scientific field preferred.
Excellent oral and written communication skills with strong technical writing experience required.
Possess an understanding of the requirements of Sample Coordination in a GMP laboratory. •
Last updated on Sep 8, 2023