Essential Duties and Responsibilities: |
• Responsible for ensuring the integrity of all data and documentation reported from the Quality Control Laboratory. |
• Experience in handling Agilent and Thermo HPLC and GC’s. Review the raw data of testing via the chromatography data acquisition system i.e. Chromeleon. |
• Review various laboratory instrument’s raw data and its audit trials such as UV, FTIR, KF, TOC analyzers, Headspace analyzers and Lab-X software for management of the off-line instrument data. |
• Review all source data and associated documentation for accuracy and cGMP conformance. |
• Review the applicable specifications for the raw material, finished product and stability studies. |
• Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made. |
• Ensures Investigations are assigned to data or documentation, as appropriate prior to data verification is signed off. |
• Responsible for verifying all laboratory testing was conducted in accordance with SOP’s as well as cGMP’s and GLP’s. |
• Review of Laboratory notebooks for completeness, and archival, as appropriate. |
• Interacts closely with Quality Management and all team members to identify and aid in the implementation of data security, integrity, or efficiency improvements. |
• Understands testing and procedures within Quality testing. |
• Performs work in accordance with general and specific safety precautions. |
• Interacts routinely with departments such as Production, QA, RA, R&D, Validation, etc. |
• Assist in performing Quality Assurance audits on laboratory areas to ensure cGMP compliance. |
• Provide support during internal and external audits related to regulatory, pre-inspection approval, and corporate compliance. |
• Assist in the investigation and review of deviation reports and OOS reports to assure complete compliant source data. |
• Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems. |