The Project Coordinator/Technical Reviewer directly supports in the daily management of multiple projects and data for our healthcare partners. Specific responsibilities include the creation and maintenance of laboratory timelines, documentation review/approval (such as chromatography, protocols, and applicable change controls), and writing notifications and deviations. Bench testing may be requested. As the laboratory point of contact with the Project Managers group, the individual needs to maintain strong professional relationships while setting realistic expectations and ensuring timely communication.
• Participate in internal, cross-functional teams to ensure project milestones are met as contracted with our healthcare partners.
• Accurately review data using validated test methods and SOPs in a cGMP environment.
• Demonstrate technical competence in the data review that is related analytical data integration. Review methods that is related to use of instrumentation & data processing to the job including, but not limited to:
o HPLC High Pressure Liquid Chromatography
o UPLC Ultra High Pressure Liquid Chromatography
o IR Infra-Red Spectroscopy
o Spray Characterization Tests
• Gather information and contribute to the writing and review of protocols.
• Attend internal and client meetings to provide communication of progress and issues.
• Responsible for writing and revising SOP’s, investigations, deviations, technical reports, etc.
• Support regulatory submission information gathering.
• Identify opportunities to improve processes/systems.
- Perform impact assessments for change controls as required.
• Responsible for analyzing data, maintaining accurate and detailed written records and notebooks and thoroughly reviewing lab notebooks ensuring compliance to test methods and specifications.
- Properly document any changes to laboratory timelines and follow up to ensure approval of same by the client and internal team members.
• Perform testing within the lab, when necessary.
• Perform other duties and responsibilities as assigned.
Bachelor’s degree required. Master’s degree preferred. A minimum of 5 years of HPLC or UPLC experience in pharmaceutical industry required.
To apply for this job please visit topspotjobs.com.