Role and Responsibilities
* Support shipping, receiving, and warehousing within cGMP guidelines
* Author deviations, change controls, and standard operating procedures within company systems
* Capable of performing, monitoring, and resolving all ERP/SAP transactions supporting department
* Ensure a superior level of accuracy and traceability utilizing the inventory management system
* Ensures compliance with DOT designated hazardous materials, 49 CFR, and IATA regulations
* Provide performance reviews to direct reports; counsels and disciplines under-performing employees
* Author, approve and implement SOPs, change controls, and non-conformances
* Ensure compliance with site regulatory and cGMP guidelines as well as company policies
* Supports and maintains costs to budget, rationalizing headcount for the department
* Interface with 3rd party contract labor support communicating performance and hourly tracking
* Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP's)
* Assist in developing warehouse budget
* Investigating and resolving problems, and identifying and implementing process improvements
* Responsible for managing the training and development of personnel
* Assist the manager in interfacing and relationship development with support departments (QC, QA, Facilities, Development, etc.) to assure production goals are met
* Sufficient understanding of the process, systems, and equipment to troubleshoot problems and provide solutions to senior management
* Expert knowledge of electronic quality systems
* Possesses strong verbal and written communication skills
* Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exist
* Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
* Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exist
* Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Qualifications and Education Requirements
* Degree required
* 4 - 5+ years of work experience in pilot or commercial pharmaceutical or manufacture under cGMP
* Minimum of 5 years previous work experience in a cGMP warehouse.
* Minimum 3 years prior supervisory, management, or leadership experience
* Must have the ability to work overtime as required.
* Strong Warehouse Management System experience using SAP or other ERP systems
* Competent with Microsoft Office applications, especially Excel. Visio helpful.
* Capable of training full-time and temporary FTEs.
