Senior Coordinator, Quality Control Sample

Role Summary

The Senior Coordinator, Quality Control Sample leads sample control support at the assigned site/laboratory. This on-site role in Durham, NC supports GMP-compliant quality control activities and coordination with cross-functional teams to ensure sample integrity and data accuracy.

Responsibilities

• Oversight of QC in-process, release, raw material, and stability, and development samples, associated document management, and data collection.
• Adherence to GMP requirements and understanding of FDA/EMEA regulations; effective interactions with Quality management; support of investigations and inspections/audits.
• Manage sample tracking and the inventory system for 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 completion when sample invoices arrive.
• Coordinate international shipments and alert logistics of any customs clearance issues.
• Inspect incoming sample shipments and take actions if samples do not comply with SOPs.
• Review and evaluate temperature data reports from 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 Quality Assurance, Manufacturing, Facilities, and other departments to address compliance issues and implement corrective actions.
• Write and revise documents such as SOPs and technical reports.
• May support training, coordination of tasks, GMP compliance, and corrective/preventive actions.
• Support stability sets and pulls including aliquoting and shipping during studies.
• Perform other related duties as assigned.

Qualifications

• Required: High School diploma with 6 years of related GMP Quality Control Laboratory experience, or Associate’s degree with 4 years of related GMP QC Laboratory experience.
• Preferred: Bachelor’s degree in a relevant scientific field with 2 years of related GMP QC Laboratory experience.
• Possess a strong understanding of sample receipt and inventory management in a GMP laboratory. Excellent oral and written communication and technical writing skills. Ability to work independently and within a team, across Quality and site functions. Ability to work with both paper-based and electronic laboratory information management systems.

Skills

• Quality control and GMP/compliance knowledge
• Data management and documentation
• Strong communication and technical writing
• Inventory and sample tracking
• LIMS and document control proficiency