Associate Coordinator Quality Control Mgmt

Role Summary

The Associate Coordinator, Quality Control Sample, leads sample control support at the assigned site/laboratory. Location: Durham, NC. This on-site role is based in Durham, NC.

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, 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 policies.
• 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.

Qualifications

• Required: High School degree with 8 years related experience in a GMP Quality Control Laboratory or Associate’s degree with 6 years related experience in a GMP Quality Control Laboratory.
• 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.

Skills

• Strong communication and collaboration across QA, Manufacturing, and Facilities.
• Technical writing and documentation proficiency.
• Independence and teamwork in a GMP environment.
• Experience with laboratory information management systems (LIMS) and documentation control.