QC Technician
2512 South Tricenter Boulevard Durham, NC 27713 US
Job Description
Job Profile 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.
- Ability to work effectively within the group, within Quality, and across the site.
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