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QA Specialist-Lot Release

Lab Support, A Division Of On Assignment

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Location: Novato, CA Posted Date: 4/17/2013 Position Type: Contract, Full time Job Code: QA Required Education: Bachelors Degree

Description

Job Responsibilities:
Review and disposition incoming raw materials for Novato manufacturing.  Receive, inspect and inventory samples for the QA reserve sample program.  Review and approve manufacturing pre-weigh kits.
-Routine raw material lot disposition, reserve sample receipt and inspection, rejected materials control, etc.)  
• Provide enhanced QA management role for Warehouse Ops activities and problem solving, including system improvements such as:
o Ensuring warehouse facilities projects proceed to completion, such as the 21 Pimentel Freezer repair, office space build out, etc.)

Requirements

• Perform routine walkthroughs of warehouse facilities for cGMP compliance and general housekeeping
• Work directly with QC raw materials (QCRM) Senior Manager to ensure a review of specification for chemical raw materials is performed and appropriate revisions are made to ensure chemical raw materials are suitable for their intended use in manufacturing operations.
• Interact directly with Review Response Board team and other inspection management staff on putting together responses for Warehouse inspection/audit observations.  
Review Warehouse Operations audit/inspection observations to ensure appropriate actions are taken.
• Work directly with the Purchasing department to determine if supplier agreements suitably address supplier quality issues for critical raw materials.  
• Work with Quality unit to ensure harmonization of standards across both Novato and Shanbally Warehouse Operations
• Help develop Global Raw Materials Quality Policy
• Review existing QARM SOPs and evaluate for compliance and to identify process  improvements.

Duties: B.A./B.S. Degree in Technical Discipline, with 1-2 years experience in a GMP environment.  Well organized and detailed oriented and able to work independently.

**Please email your resume to lisa.kwan@labsupport.com and use QA specialist as the subject line.

ONLY LOCAL CANDIDATES WILL BE CONSIDERED.
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