QC Lead Analyst

• Responsible for scheduling/coordination of laboratory activities (routine GMP testing throughput).
• Demonstrate awareness of the scientific principles and method validation for the assays which they perform.
• Review GMP assay data and communicate findings to manufacturing teams.
• Prioritize and decide appropriate course of action with minimal supervision.
• Lead lab investigations
• Coordinate and schedule preventative maintenance activities with external vendors
• Perform revision of standard operating procedures, act as Process Owner for applicable methods.
• Train/teach team members on applicable procedures
• Serve as subject matter expert on various methods/topics
• Coach other members of team and influences situational adaptability across department
• Effectively communicates across departments on site
• Leads others through high pressure situations, reacts calmly under stress
• Support non-routine tests, studies or projects
• Support the qualification, operation and scheduled maintenance of laboratory equipment, including automated and computerized systems and assure they remain in a functional, validated state. Escalate issues associated with equipment and assays as required.
• Understand and comply with current GMP regulations and quality systems. Promotes a quality mindset in every action, every day by routinely communicating concerns, issues and best practices.
• Accountable for supporting QC and site operations, communicating in a positive, professional manner, supporting operational excellence principles and supporting and implementing management decisions
• Responsible for application of GSK safety and environmental guidelines and identification, escalation and prevention of safety issues. Duties may include minimal handling of hazardous waste from laboratory activities to satellite storage areas. Annual training on area-specific hazardous waste handling is required. This training satisfies annual RCRA training requirement for large quantity generators and is part of the site’s RCRA compliance program.
• Assist in maintaining area of responsibility in a state of inspection readiness
• Performs other departmental duties as assigned by management
  
  

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree in a scientific discipline
• 2+ years GMP/pharmaceutical/lab experience
  
  

Preferred Qualifications:

• Computer skills and knowledge; basic proficiency with Microsoft Office programs.
• Demonstrated ability to work successfully both independently and in a team environment
• Good verbal and written communication skills
• Good time management skills
  
  

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.