Education or Equivalent: Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required.
• Minimum of 2-5 years of experience in a cGMP regulated environment required.
• Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred.
• Extensive experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses required.
• Demonstrated ability to lead and/or author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required.
• Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred.
• Experience with analytical method development and validation preferred.
• Familiarity with executing Standard Operating Procedures in a GMP setting required.
• Chromatography skills using Empower and/or ChemStation required.
• Critical understanding of the importance of documentation and data traceability required.
• Working knowledge of cGMP’s and their application to Quality Control required.
Other Skills and Abilities:
• Excellent oral and written communication skills.
• Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities.
• Demonstrates dedication to documentation/data traceability and strong attention to detail.
• Demonstrates appropriate safety consciousness.