- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
- These engineers, technicians, scientists and support staff build and maintain our company’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
- Come join our team and make a meaningful impact on patients’ lives.
- The QC Micro Technical Support Associate reports to the QC Technical Support Manager and is responsible for supporting QC activities to ensure QC commitments are met.
- Together with the QC Technical Support Manager this role is responsible for ensuring the department architecture and vision is in place to meet company needs.
- Driving method development / verification and validation of Microbiological methods with sister site for the introduction of New Products
- Writing and Management of Protocols and Reports associated with the introduction of new methods example Bioburden and Endotoxin qualifications
- Provide Microbiological technical expertise to the QC team with respect to method and equipment troubleshooting and compliance activities
- Provide technical mentoring and feedback to the team. Sharing technical knowledge to ensure continuous improvement, technical development and promoting best practices, with particular emphasis on Microbiology
- Collaboration with QC Leads and Associates to ensure the overall running of the QC Laboratory
- Review and approve documentation on behalf of QC such as standard operating procedures, training modules, protocols, reports and Trackwise
- Management and communication of QC metrics such as Site routine metrics, Safety and compliance expectations
- Liaise and support Site Microbiologist when required
- Ensure compliance to GxP, safety and environmental standards
- Conduct and document out-of-specification/out-of-trend result investigations
- Provide QC support for site plans, protocol executions, and summary reports
- Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
- Lead and implement initiatives that add value to QC Operations