Pharmacologist
Title: Pharmacologist
Location: Albany, OH
We are working with a key client to find a dedicated Pharmacologist to join their team! Please see the responsibilities below:
- Plan and conduct cutting-edge pharmacology studies for effective drug development.
- Design pharmacological studies, collaborating closely with cross functional colleagues.
- Perform quantitative and qualitative pharmacology analyses, interpret study results and make recommendations based on findings.
- Assist with pharmacokinetics, collaborate with cross-functional teams including laboratory technicians
- Collect and analyze data from various process areas, defect reports and performance metrics.
- Perform batch trending analysis.
- Design tests, perform data analysis and regulatory inspections for pharmacological studies.
- Prepare controlled documents (e.g. SOP's Batch Records, Specifications, Protocols, Deviation reports, OOS investigations).
- Drive continuous improvement efforts for pharmacological studies through monitoring/evaluation of site systems & processes aligned with GMP and FDA requirement.
- Provide quarterly metrics/trends regarding pharmacological studies to the General Manager and to the Quality Director.
- Participate in cross functional teams in preparation for regulatory inspections, quality agreements, internal and external audits, validation activities and special projects.
- Stay current with applicable laws, federal and pharmacy regulations, and company quality standards.
- Contribute to the development, management, harmonization and improvement of quality systems and procedures to ensure compliance.
- Oversees Sterility Assurance
If this sounds interesting, please apply in for more information!
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