Associate Specialist Quality Control

PSC Biotech is a leading Biotech Consultancy firm seeking an Associate Specialist Quality Control to provide technical support to the QC Microbiology Lab & operations. The role requires a high level of leadership, initiative, collaboration, and coaching to facilitate the team in becoming a high-performance organization. The ideal candidate must have the ability to own and manage projects and deliver on required timelines.

Requirements

• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures
• Supporting and owner of Environmental monitoring risk assessments and qualification
• Generation of quarterly and annual trend reports
• Understanding and applying regulatory/compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes
• Development and execution of Microbiology test methods and project validations
• Troubleshooting of issues which arise during the execution of validation studies and routine tests
• Development of training modules
• Microbiology Support to Site Investigations and projects relating to environmental monitoring and utilities monitoring
• Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment
• Authoring and managing change controls, procedures, test methods and deviations
• Result authorization for microbiological samples to support batch release
• GLIMS System updates
• Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control
• Supporting lab stock management and financial control as required
• Interpreting customer needs, assessing requirements, and identifying solutions to non-standard requests
• Making decisions within guidelines and policies which impact microbiology projects
• Ensuring highest safety standards
• Performing other duties as assigned

Benefits

• Competitive salary
• Permanent contract of employment
• Opportunity to work with top pharmaceutical clients
• Diverse-cultural work setting
• Unparalleled empowering career development
• Learning & Development in-house training
• Mentorship and guidance