Job Title: Quality Administrative Specialist
Location: Smyrna, GA Hybrid role- 2 days onsite, 3 days remote
Duration: 06 Months on W2 (Temp to hire)
JOB DESCRIPTION:
PRIMARY RESPONSIBILITIES:
The goal of this function is to support the Quality Management Systems in the U.S.
Affiliate, including but not limited to the following:
Ensure global quality practices are integrated in the affiliate to ensure compliance is met regarding and local regulations.
Maintain the GXP status of the affiliate in accordance with national and international GMP and legal requirements.
Ensure QA deliverables are achieved in a compliant timely manner.
Support Local Quality Lead in tasks.
MAJOR RESPONSIBILITIES:
Describe the main accountabilities for this role including significant tasks, responsibilities, and projects.
Ensure implementation and maintenance of the local Quality Management System elements listed below to drive compliance of all relevant cGXPs with local/International regulatory requirements and global standard operating procedures.
o Quality Management Review
o Quality System Monitoring
o Quality Risk Management
o Document and Record Management
o Staff Qualification (Update of Training Plans)
o Deviation Management
o Investigation Process
o CAPA Management
o Change Control Management
o Product Complaint Management
o Internal and External Audit Management (supporting role)
o APQR
o Retained Sample Management
o Distribution Management
o Batch Disposition and Release Management
o Recall Management
o Local Vendor Management
o Product Returns
Provide support, as deemed necessary, to the Quality Lead and Quality Partners or execute the QMS tasks not listed above under oversight from the Quality Lead or Quality Partners.
Ensure Quality deliverables listed above are completed in a timely manner in accordance with Corporate QMS and KPIs.
Ensure efficient information flow and effective communication of quality matters within the relevant Affiliate organization to the Quality lead including but not limited to issue escalation.
Support ad-hoc projects at the affiliate, as needed.
Support Global projects on quality systems, as needed.