Ensure the proper upkeep of equipment and systems in the QC IPC/DS laboratory to maintain full compliance with cGMP standards as part of the shift team.
Conduct product testing and analysis in accordance with cGMP guidelines to meet specified deadlines.
Offer technical assistance in running and validating necessary testing methods on laboratory equipment and in the development of method transfer/validation protocols and reports.
Conduct routine analytical testing for in-process, release, stability test, and validation samples, including but not limited to HPLC, UV, TOC, pH, and more.
Effectively manage work priorities to ensure timely document review and testing.
Create and review QC documents, encompassing assays of varying complexity, to guarantee their completeness, accuracy, consistency, and clarity, ensuring that materials or final products align with specifications and cGMP standards.
Prepare for and participate in inspections by health authorities and internal audits within the respective area.
