The Inventory Control Manager is responsible for overseeing archive activities and implementing systems to ensure compliance with GLP (Good Laboratory Practice) requirements. They will assume leadership duties to efficiently coordinate assigned personnel, ensuring consistency in procedures through personnel training.
Responsibilities:
Develop and manage computerized files to support archive processes.
Coordinate the reception, review, indexing, labeling, and archiving of study and facility materials.
Supervise the check-in and check-out procedures for archive materials.
Correspond with Sponsors regarding the end of retention periods and maintain records of Sponsor communication for accessibility.
Manage and document the disposition of study materials based on Sponsor requests.
Identify and propose process enhancements for the department.
Review and revise archiving standard operating procedures.
Represent the company during Sponsor and regulatory visits by conducting archive tours and providing requested information.
Delegate daily tasks to Archive staff and lead process improvement initiatives.
Provide training to other employees as necessary and serve as a backup for supervisory duties.
Conduct training seminars and distribute information on GLP regulatory requirements for archive processes.
Assist with document reviews.
Qualifications:
Bachelor's degree with at least 2 years of related experience, or equivalent combination of education and experience.
Minimum of 2 years of experience in a regulated environment.
At least 1 year of supervisory experience.
Proficiency in Microsoft Office products.
Strong communication skills, both written and verbal, with the ability to effectively communicate with various stakeholders.
Continual training in GLP, computer software applications, and archive processes.
Ability to multitask and maintain organization in a fast-paced, changing environment.
Understanding of regulations pertaining to archive responsibilities.
Demonstrated presentation and facilitation skills.