QA Specialist - Level 1 US
The Operational Quality Technician will be responsible for working on the shop floor supporting site operations and addressing quality issues during production shift operating hours. This position requires knowledge of most aspects of the QA team and the need to be familiar with plant operations. Additional responsibilities include supporting incident and deviation investigations, participation in internal auditing activities, and the management of materials. Additional responsibilities include approving line clearance activities, GEMBA activities, QIR investigations and batch record review assistance as required.
• Participate in the Excellence for Deviation Management (eDM) program and certify as a Quality Deviation Approver
• Perform Rapid Response and Root Cause Analysis investigations for Quality Incidents in operations with involved operators to ensure full understanding of the incident at the time it occurred.
• Ensure products are produced to the correct specification and per the operating instructions for all markets meeting compliance with registered details and TTS agreements.
• Assist in managing consumer complaint investigations, as required.
• Execute and/or assist in self-inspections and level 2 internal auditing programs.
• To ensure that all batch implicating issues are highlighted and resolved without delay to batch release and/or impact to compliance/regulatory requirements.
• Comply with all operational safety, process safety, environmental permits, Quality policies, procedures and training requirements
• Ensure quality and compliance in accordance with established procedures and standards of the Quality System.
• Comply with and support the GSK Environmental, Health and Safety policies and procedures.
• Effectively and compliantly write and manage the activities required to execute rework and AQL activities; including training and knowledge of Regional Distribution Center procedures and processes applicable to the site.
• Create batch packets (primarily off-shifts) to support operations as required.
High school diploma or equivalent
A high school diploma is sufficient to manage the job responsibilities and duties within the Quality organization.
Computer skills and pharmaceutical background
An associate level would aid in managing the work and identifying solutions to meet the Quality Assurance areas of a complex business operation and meet Regulatory Agency expectations.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
your application has been submitted
Back to job search