Jobs in All Categories (16) Engineering & Construction (2) Operations & General Management (6) Science & Education (7) Technology (1)
Directs the batch record review and lot disposition activities, including raw materials, to ensure release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals.
Build and maintain successful cross-functional relationships with internal customers such as Manufacturing, Process Development, Analytical, Quality and Facilities Engineering.
The Sr. Manager, Warehouse provides leadership by overseeing all functions and employees in receiving, warehousing, materials, and inter-location inventory transfer.
Provides strategic oversight and leadership to the QA Analytical team to ensure quality objectives are attained related to projects and business drivers.
Ensure completion of project team assigned QC related activities; coordinate product and raw material testing with external testing laboratories.
Requires the ability to produce results in a fast-paced environment, under minimal supervision while leading/managing junior staff.
Work with Facilities and Engineering, maintain equipment database information including updates when equipment is acquired, moved, or decommissioned, or equipment standards are revised.
Execute document control processes and systems for GMP activities in compliance with internal procedures and policies, as well as, regulatory requirements.
Able to work in team oriented environment working closely with clients, Project Management, Process Development, GMP manufacturing and Quality.
Communicates effectively with manufacturing managers, supervisors, and schedulers to assure production plans and schedules.
Displays exceptionally strong technical knowledge, initiative and scientific commitment, and makes significant scientific and technical contributions within the Microbial Process Development group.
Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.