Stability Coordinator I

Alcami Corporation•Wilmington, NC

5d•Onsite

About The Position

The Stability Coordinator I supports client stability programs by generating protocols and facilitating sample and project login for laboratory documentation and data reporting. The role provides administrative and organizational support for stability storage activities, including protocol generation, sample receipt, inventory, testing login, transfer and shipment, and storage. The coordinator maintains accurate, up-to-date electronic documentation and files accessible to appropriate personnel. This is a 100% on-site, first-shift position, Monday through Friday, 8:30 a.m. to 5:30 p.m., with up to 5% travel.

Requirements

Bachelor’s degree with 0–2+ years of related experience, or a high school diploma/GED with at least 4 years of related experience.
Ability to multitask with strong attention to detail.
Excellent verbal communication and presentation skills.
Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
Self-motivated, reliable, detail-oriented, and a proactive team contributor.

Nice To Haves

Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or an equivalent field.
Prior cGMP experience.
Laboratory experience and/or experience with compendial testing.
Working knowledge of computer-based networks and document management systems.
Strong understanding of pharmaceutical manufacturing and testing.
Working knowledge of cGMP in a pharmaceutical or regulated environment.

Responsibilities

Use multiple computer software programs to log in and generate projects for laboratory testing; manage projects and maintain stability sample status, pull points, and testing requirements.
Manage and maintain testing requirements in electronic systems according to approved stability protocols and revisions.
Generate and review stability storage protocols that outline schedules and required testing.
Receive incoming samples for stability storage and initiate chain-of-custody tracking in electronic inventory.
Complete stability sample pulls and prepare samples for internal and external shipment.
Support client notifications for sample destruction and prepare dispositioned samples for pickup.
Complete, organize, and maintain DEA Form 222 and internal company documentation for receipt, transfer, and shipment of controlled substances as required; support controlled-substance accountability activities, including regular inventory and documentation review.
Respond to the environmental monitoring system for stability chambers.
Support stability inventory maintenance and routine review.
Perform documentation accurately and completely.
Comply with safety policies and procedures.
Communicate and collaborate routinely with other departments and clients.
Complete required company training on time and comply with cGMP, EHS, DEA, and other relevant requirements.
Perform other duties as assigned.