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Drug Product Operations Sample Coordinator

Alcami Corporation Wilmington, NC

Wilmington, NC

Today

Full time Chemical Logistics Management Operations Management

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Job Description

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.

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