Pharma Drug Product Sample Coordinator On-Site Lab

Alcami Corporation; Wilmington (NC); On-site; USD 60,000 - 75,000; Full time

Job summary

Alcami Corporation in Wilmington, NC is seeking a Drug Product Operations Sample Coordinator to drive on-time sample intake, chain-of-custody, and transfer of materials from manufacturing to the laboratory. You will manage project timelines for COAs and maintain accurate documentation for audit readiness.

The role collaborates with Manufacturing, Formulation, Project Management, Laboratory and Quality teams to ensure batch records and specifications are released on schedule, while upholding cGMP

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field.
• Minimum 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.
• Samples involve raw materials, bulk drug substances, components, formulation prototypes, in-process and finished drug products.
• Manages the labelling, storage, chain-of-custody, and disposition of samples (including controlled substances).
• Uses computer software programs to generate projects for laboratory testing.
• Collaborates with Manufacturing, Formulation, Project Management, Laboratory and Quality teams to ensure batch records and specifications are released.
• Coordinates and schedules the raw material and components sampling for testing, and transports samples from manufacturing to labs.
• Sets committed dates and monitors laboratory testing status to ensure COA is issued on time.
• Conducts weekly meetings and communicates with key stakeholders.
• Handles logistics for outsourcing work from quotes to receiving results.
• Performs documentation accurately and completely.
• Complies with safety policies and procedures.
• Works in a team, multi-tasking in a high-pace environment with cgmp/EHS/DEA training.

Skills

Multitasking

Attention to detail

Verbal communication

Microsoft Office

Education

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

High school diploma or GED with 4 years related experience

Tools

Microsoft Office Suite

Job description

Alcami Corporation in Wilmington, NC is seeking a Drug Product Operations Sample Coordinator to drive on-time sample intake, chain-of-custody, and transfer of materials from manufacturing to the laboratory. You will manage project timelines for COAs and maintain accurate documentation for audit readiness.

The role collaborates with Manufacturing, Formulation, Project Management, Laboratory and Quality teams to ensure batch records and specifications are released on schedule, while upholding cGMP