QA Specialist - Level 1 US K3J-816

You are viewing a preview of this job. Log in

or register

to view more details about this job.
Hybrid Schedule: expected to be on-site at least 2 day per/week, more if needed
This position is actually located at the Dstribution Center in Manchester, PA
Top Skills:
• Knowledge of regulations, guidance, and industry standards related to the systems (for example: GSK, GMP, GDP, WHO, PDA, ASTM, IATA, etc.)
• Good knowledge of quality systems, e.g. Deviation, Documentation Management, Training, Change Control, CAPA, Risk Management, Validation.
• Demonstrated impact and influence skills
• Excellent organizational skills and attention to detail.
• Demonstrate a serious commitment to accuracy, integrity, and quality while meeting goals and deadlines
• Excellent English knowledge, written and spoken.
Education Requirements: Bachelor/University Degree in a related field
Experience Requirements: Minimum 1 year of QA experience in a pharmaceutical/biological production environment. Direct experience with GxP regulated environment within major authority jurisdiction (FDA / EU / WHO Audit)
********************
Responsible for oversight of the operational QA activities at the NA RDC
• Work closely with NA RDC personnel and GSK staff at NA RDC to ensure continuous supply of vaccines in line with regulatory and GSK Vx quality requirements
• Ensure NA RDC Quality System for services provided to GSK Vx is in compliance with relevant regulations and with GSK Vx requirements/processes
• Manage NA RDC distribution quality related activities in GSK Vx SAP (e.g., cold chain correction, management of TOR)
• SAP unplanned event management, to include creation, encoding, and/or approval of the unplanned event notification
• Cold Chain Time out of Refrigeration (TOR) management in SAP, to include performing correction, documenting it in unplanned event, and/or double check of another user’s cold chain correction
• Quality oversight of inbound and outbound operations at NA RDC
• Proactively identify and potential quality and compliance risks related to NA RDC and actively work on mitigation plan

#J-18808-Ljbffr