Quality Assurance Specialist II – Night Position Summary: Catalent is a global, high-growth, public company... unit of its kind for DPI in North America. Catalent Pharma Solutions is hiring a Quality Assurance Specialist II...
, and approve site Standard Operating Procedures. Review Batch Records and provide final product disposition. Review and assess...Objective The Quality Assurance Specialist I will support the design, implementation and maintenance of QA...
Quality Assurance lot release and disposition activities including process observation, batch record review, and completion... products. Support quality assurance processes, controls and batch history files for QA Operations and Lot Disposition Perform...
Quality Assurance lot release and disposition activities including process observation, batch record review, and completion... of AMTAGVI and associated growth has led to the creation of a new position. The Specialist I - IOVA-A QA Ops will be a key role...
to Manufacturing Associates to meet batch record review/disposition schedule to adhere to lot release dates. The Specialist II, MTO...Specialist II, MTO Summary: Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies...
for several open roles. We are seeking highly motivated Quality Operations Specialist II to join the facility’s Quality Operations team... regulations, as well as internal policies and procedures. The Specialist, Quality Operations, will work alongside manufacturing...
Overview The Quality Operations Specialist II is a part of the Quality Operations team. The Quality Operations team... and procedures. The Quality Operations Specialist II works alongside manufacturing personnel, helping to ensure that the highest...
to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor... for participating in necessary research to determine root cause, corrective/preventative actions, product disposition, and using the...
systems batch release, and/or relevant quality processes are compliant with regulations. Has product release authority if role... is in batch release. Quality oversight, review & approval of validation activities and documents associated with projects, new...
systems batch release & other relevant quality processes are compliant with regulations e.g.: 21CFR part 211. Has product... release authority (Authorized Qualified Person), if role is in batch release. Serve as Quality oversight, review & approval...
work orders for manufacturing and maintains a completed work order file system. Responsible for month end job, batch... identification, isolation, segregation and disposition of non-conforming materials or products. Maintain quality records. Provide...
investigations and deviations Review and approve documents including: CMO Manufacturing batch records, lot disposition documentation...Description Responsible for batch record review Assess CMO batch compliance with FDA and ICH regulations Support...
systems batch release & other relevant quality processes are compliant with regulations e.g.: 21CFR part 211. Has product... release authority (Authorized Qualified Person), if role is in batch release. Serve as Quality oversight, review & approval...
systems batch release, and/or relevant quality processes are compliant with regulations. Has product release authority if role... is in batch release. Quality oversight, review & approval of validation activities and documents associated with projects, new...
and delivery of training on quality related topics. Provide support for review of batch records, cleaning records, conducting line... certifications). * Support investigation processes and leads investigations as necessary. Provide disposition for the receipt...
or offline. Performs activities specified in batch record and SOP’s. Sample and evaluate product per defined methods, recognizes... action levels and notifies area specialist and supervisor if out of limits. Perform and document lot changes, line...
. Manage batch record review and lot closure. Approve documentation from third-party warehouses. Handle lot release... and disposition activities. Support raw material, component, and kit release for manufacturing. Lead or support investigations...
transactions, proper batch/lot assignment, and material disposition. Who Will Love This Job An efficient worker, you enjoy... differential) The Role: The Quality Assurance Tester Specialist is responsible for the Acceptance Testing of the materials...
policies and practices. Responsible for accurate and timely documentation of work in batch records, log books... either as inherent part of the production process or off line. Performs activities specified in batch record and SOP's. Sample...
policies and practices. Responsible for accurate and timely documentation of work in batch records, log books... either as inherent part of the production process or off line. Performs activities specified in batch record and SOP's. Sample...