Overview
GMP Quality Specialist Jobs in Wilson, NC at The Fountain Group
Title: GMP Quality Specialist
Company: The Fountain Group
Location: Wilson, NC
Details:
Pay for this position is 43.00 to 45.86 hourly depending on experience.
This position is a one year contract with the possibility of conversion to permanent.
Location: Wilson, NC (100% onsite)
Requirements:
Must possess a B.A. /B.S. degree (preferably in Science or Engineering).
Must possess a minimum of minimum of three (3) years’ experience in a GMP pharmaceutical manufacturing facility with either direct involvement in Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as: batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.
Responsibilities:
The responsibilities of the Specialist, Quality Assurance include, but are not limited to, the support of batch record management, retrieval and generation of batch conformance documentation (CoC and CoA), completion of batch record reviews for domestic market, intermediate and finished product releases for domestic market, support site Quality owned investigations, data compilation/support for internal/external audits and regulatory inspections, SOP development and review, Supplier Quality Management and other Quality Assurance related functions as required.
Retrieval and tracking of site Batch Records including, but not limited to, retrieval from Operations, archiving into the appropriate tracking system, scanning for Canadian market, and filing in applicable Document Retention room.
Tracking, retrieval, storage (including shipping offsite), execution of retrieval challenges, and destruction of batch records beyond retention period as applicable.
Batch record review and intermediate/finished product release activities for domestic distribution.
Provides Quality Assurance review and approval of GMP-related SOPs. Assist in the development of procedures to improve compliance status of Wilson operations.
