Technical Operations Specialist - for a Leading Biotechnology Corporation
- Operations Team
- The greater San Francisco, CA area
Technical Operations Manager Summary
A leading Biopharmaceutical manufacturing company is seeking a Manufacturing Lead to join the Operations leadership team in their San Francisco Facility! This individual will be responsible for the design, implementation, and maintenance of the IxRS to support clinical trials. They will lead and manage employees to uphold company standards, achieve business targets, and operate within budget.
If you are someone who can contribute to keeping this organization on the path of success, then please apply today!
Technical Operations Specialist will have the following Responsibilities:
- Manage interactive response technology (IxRS) processes
- Ensure operations are compliant with Good Clinical Practice standards
- Review IxRS supplier documents and ensure they uphold company requirements
- Responsible for following and training company quality system regulations and processes
- Ensure company quality standards are being upheld by performing various quality processes
- Ability to set and achieve business short-term and long-term targets
- Develop, implement, and uphold SOPs that comply with company and other regulatory standards
- Participating in projects and providing ideas for continual process improvement
- Develop technical solutions to any problems that may arise
- Perform clinical data system audits
Technical Operations Specialist will have the following skill set:
- Bachelor's degree required, degree in the life sciences preferred
- Masters preferred
- 3+ years' experience in a clinical trial environment
- Experience working in a research environment with the focus in biotechnology or pharmaceutical industries
- Working knowledge of the manufacturing processes
- Working knowledge of EHS, FDA, Good Clinical Practice, and other regulatory standards
- Able to manage multiple processes in various clinical trial areas
