Description

Perform daily QA activities to support GMP Analytical projects, nonGMP/GMP Manufacturing Facility operations, and other duties as notified by management.

► Perform approval process for analytical procedures.

► Perform approval process for analytical protocols/reports. Maintain controlled documents.

► Perform approval and release of regulated raw materials and intermediates.

► Review and approve analytical data used in the support of raw material, intermediate, and final product batch release.

► Knowledge and use of computerized quality systems such as Empower, MasterControl, TrackWise, and SAP.

► Develop and issue Certificates of Analysis.

► Assist with management and issuance of notebook system.

► Ensure compliance with company policies and SOPs, as well as FDA and other applicable guidelines.

► Assist with developing and maintaining Cambrex's quality system.

► Assist with developing and performing training activities.

Occasional Duties:

► Assist with development and writing of standard operating procedures.

► Serve as a backup to Senior Quality Assurance Scientist and management.

► Other duties as assigned and/or developed by Quality Management.

► In the absence of Manager/Associate Director, Quality, sign certificates and forms following

written authorization from management

► Assist with development and writing of standard operating procedures.

► Serve as a backup to Senior Quality Assurance Scientist and management.

► Other duties as assigned and/or developed by Quality Management.

► In the absence of Manager/Associate Director, Quality, sign certificates and forms following

written authorization from management

BS or MS in Chemistry (or closely related discipline) or relevant experience. A minimum of 5 years of relevant background in GXP compliant pharmaceutical laboratory environment or related quality area.

Ability to create and interpret SOPs. Ability to work with minimal supervision.

PI281674222