Category

Description

Job description
Duties

Collect data from multiple QC labs and coordinate any corrections.
Scan Lot Release, Reference Material, Cell Bank into validated system.
Manage the archival of lot release, tox lots, and CMO data
Maintain database for all documents received.
Coordinate the preparation and retrieval of data to and from offsite storage location.
Receive, manage, and distribute Clinical Sampling Plans, Protocols, Memos, CMO CoAs, Testing Request Forms.
Manage and drive to completion requests from different QC groups.
Compile analytical data for bulk, final product.
Adhere to cGMP compliance guidelines.
Support internal and external audits (as needed).
Accomplish corporate, operational and departmental goals
Apply expertise of compliance requirements to maintain an inspection-ready state.
Train personnel on relevant business processes.
Provide data and documents to support product quality impacting investigations
Collect data from multiple QC labs and coordinate any corrections.
Scan Lot Release, Reference Material, Cell Bank into validated system.
Manage the archival of lot release, tox lots, and CMO data
Maintain database for all documents received.
Coordinate the preparation and retrieval of data to and from offsite storage location.
Receive, manage, and distribute Clinical Sampling Plans, Protocols, Memos, CMO CoAs, Testing Request Forms.
Manage and drive to completion requests from different QC groups.
Compile analytical data for bulk, final product.
Adhere to cGMP compliance guidelines.
Support internal and external audits (as needed).
Accomplish corporate, operational and departmental goals
Apply expertise of compliance requirements to maintain an inspection-ready state.
Train personnel on relevant business processes.
Provide data and documents to support product quality impacting investigations

Skills
Sound knowledge of cGMP or equivalent regulations
Ability to interpret Quality standards for implementation
Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
Ability to communicate clearly and professionally both in writing and verbally Flexibility in problem solving and work hours to meet business objectives
GMP experience preferred with particular emphasis on Quality Control
Experience working with Labware LIMS, SAP and Trackwise are preferred

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