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