Drug Product Lab Sample Coordinator — COA & Materials

Alcami-5; Kirkland (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Alcami is seeking a Drug Product Operations Sample Coordinator to log samples, initiate chain-of-custody, and coordinate sampling and transfer of materials from manufacturing to the laboratory, while managing timelines for COA issuance.

The role provides administrative support for materials management in manufacturing and requires accurate documentation, with a focus on cGMP, EHS, and DEA training compliance, on-site 1st shift, and a willingness to travel up to 5%.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related field preferred.
• High school diploma or GED and a minimum of 4 years of related experience required.
• Pharmaceutical, CDMO, or cGMP experience strongly preferred.

Responsibilities

• Receives incoming samples for laboratory testing and initiates chain-of-custody tracking in electronic system.
• Manages labeling, storage, chain-of-custody, and disposition of samples (including controlled substances).
• Coordinates sampling and transfer of materials/components from manufacturing to the laboratory.
• Generates projects for laboratory testing using computer software; experience with analytical testing is a plus.
• Collaborates with Manufacturing, Formulation, Project Management, Laboratory and Quality teams to ensure batch records and methods are released.
• Sets committed dates and monitors status to ensure COA is issued on time.

Skills

Chain-of-custody tracking

Laboratory coordination

Documentation

Multi-tasking

Microsoft Office

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field

Tools

Microsoft Office

Job description

Alcami is seeking a Drug Product Operations Sample Coordinator to log samples, initiate chain-of-custody, and coordinate sampling and transfer of materials from manufacturing to the laboratory, while managing timelines for COA issuance.

The role provides administrative support for materials management in manufacturing and requires accurate documentation, with a focus on cGMP, EHS, and DEA training compliance, on-site 1st shift, and a willingness to travel up to 5%.