Lead Stability Coordinator

Alcami Corporation•Garner, NC

1d•Onsite

About The Position

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. The Lead Stability Coordinator is accountable for driving results in a fast-paced environment by generating protocols and facilitating the log in of samples and projects for lab documentation and reporting of data for client stability programs. This position is recognized as an expert in their functional area and in regulatory knowledge associated with Stability across company departments. The Lead Stability Coordinator provides leadership and guidance related to stability storage activities, including protocol generation, sample receipt, inventory, login for testing, transfer/shipment, and storage. Provides support responding to audit requests during client regulatory inspections, regulatory interacting with agency and clients directly. Supports audit response generation as needed.

Requirements

Bachelor’s degree with 10+ years of related experience or high school diploma/ GED with a minimum of 15+ years of related experience required.
Prior cGMP experience required.
Ability to multi-task with high attention to detail skills required.
Superior knowledge in SOPs and Regulatory documents associated with department functions.
Excellent verbal communications and presentation skills required.
Ability to effectively train and mentor others.
Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
Self-motivated, reliable, detail-oriented, and a proactive team contributor.

Nice To Haves

Bachelor’s degree in Pharmaceutical Sciences, Chemistry or equivalent preferred.
Laboratory experience and/or experience with compendial testing is preferred, as this experience provides a solid foundation for the technical aspects of project creation and management.
Expert knowledge of computer-based networks and document management systems preferred.
Expert knowledge of Stability systems in a GMP facility.
Strong understanding of pharmaceutical manufacturing and testing preferred.
Expert knowledge of cGMP in a pharmaceutical or regulated environment preferred.

Responsibilities

Oversees the generation of stability studies and leading efforts to interpret and apply regulatory knowledge applicable to their department effectively, while also mentoring junior team members in their development of these critical competencies.
Generates updates existing and creates new procedures, presentations, and marketing content as applicable.
Provides support responding to audit requests during client regulatory inspections, regulatory interacting with agency and clients directly.
Supports audit response generation as needed.
Recognized SME in functional area of stability.
Leads implementation of new processes/ significant process revisions.
Works to simplify processes and strengthen quality controls.
Generates training content and acts as a mentor for others.
Uses multiple computer software programs to log in / generate projects for laboratory testing.
Manage projects, and to maintain stability sample status, pull point, and testing requirements.
Manages and maintains testing requirements in electronic systems per the approved stability protocols and revisions.
Generates and reviews stability storage protocols, outlining schedule and required testing.
Receives incoming samples for stability storage and initiates chain-of-custody tracking in electronic inventory.
Completes stability sample pulls and prepares both internal and external shipment of samples for shipment.
Supports client notification for sample destruction & prepares dispositioned samples for pickup.
This position may be required to complete, organize, and maintain DEA Form 222 and internal company documentation for receipt, transfer, and shipment of controlled substances in accordance with current Alcami and DEA standards.
Additional requirements may include support of controlled substances accountability activities, including regular inventory and documentation review.
Responds to the environmental monitoring system for stability chambers.
Supports stability inventory maintenance and routine review.
Performs documentation accurately and completely.
Complies with safety policies and procedures.
Communicates and collaborates routinely with other departments and clients.
Ensures timely completion and compliance with cGMP, EHS, DEA, and all other relevant company training requirements.
Mentors and trains others.
Other duties as assigned.