Drug Product Operations Sample Coordinator

Alcami Corporation is seeking a Drug Product Operations Sample Coordinator in Wilmington, NC to coordinate sample intake, lab documentation, and COA-related project timelines.

Responsibilities

• Receive incoming samples for laboratory testing and initiate chain-of-custody tracking in an electronic system.
• Manage labeling, storage, chain-of-custody, and sample disposition, including controlled substances.
• Use computer software programs to generate lab testing projects.
• Coordinate with Manufacturing, Formulation, Project Management, Laboratory, and Quality teams to support release of batch records, analytical methods, and specifications.
• Coordinate and schedule raw material and component sampling for testing, including responsibility for transport of samples from manufacturing to labs.
• Set committed dates and monitor laboratory testing status to ensure COA issuance on time.
• Conduct weekly meetings and provide routine communication to key stakeholders.
• Handle outsourcing logistics, including requesting quotes and POs and receiving results for reporting.
• Maintain accurate, complete documentation for appropriate personnel.
• Ensure ongoing compliance with safety policies and procedures.
• Perform in a team setting with the ability to multi-task in a fast-paced environment.
• Ensure timely completion and compliance with required training and applicable standards including cGMP, EHS, DEA, and all other relevant company training requirements.
• Complete other duties as assigned.

Sample and project scope

• Samples may include raw materials, bulk drug substances, components, formulation prototypes, in-process, and finished drug products.

Requirements

• High school diploma or GED plus a minimum of 4 years of related experience.
• Strong multi-tasking ability and attention to detail.
• Excellent verbal communication and presentation skills.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).
• Laboratory experience with analytical testing is preferred.

Preferred qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related field.
• Pharmaceutical, CDMO, or cGMP experience.

Knowledge, skills, and abilities

• Working knowledge of computer-based networks and document management systems.
• Understanding of pharmaceutical manufacturing and testing.
• Working knowledge of cGMP in a pharmaceutical or regulated environment.

Technologies

• Chain-of-custody tracking in an electronic system.
• Computer software programs for project creation.
• Microsoft Office (Word, Excel, PowerPoint).

On-site schedule

• 100% on-site role in Wilmington, NC.
• First shift: Monday to Friday, 7:30am to 4:30pm.

Travel expectations

• Up to 5% travel required.

Physical demands and work environment

• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Regular requirements: use hands to finger, handle, or feel; reach with hands and arms; talk or hear; smell.
• Frequent requirement: sit.
• Occasional requirements: stand; walk; stoop, kneel, crouch, or crawl.
• Lifting/moving: regularly up to 10 pounds; frequently up to 25 pounds; occasionally up to 50 pounds.
• Vision requirements: close vision, distance vision, color vision, peripheral vision, depth perception, ability to adjust focus.
• Occasional exposure to moving mechanical parts and vibration.
• Noise level: usually very quiet.