Supervisor, Quality Control and Reports

Inotiv•West Lafayette, IN

About The Position

As the Supervisor of Quality Control and Reports, you will lead the daily operations of the data review team to ensure the scientific integrity and regulatory compliance of all bioanalytical studies. You are responsible for developing robust QC processes—including checklists and SOP guidance—that guarantee 100% accuracy in data, tables, and laboratory documentation. Beyond oversight, you will act as a technical mentor, providing training on data integrity and identifying process improvements to enhance efficiency while maintaining strict adherence to pharmaceutical industry standards. Enter data into databases Follow SOPs and other applicable laboratory or company procedures Maintain confidential information General Interact with the community and employees Support and participate in other company initiatives as directed by senior management Perform other duties as assigned Specific Coordinate all Data Review day to day activities Develop processes adequate to the regulatory requirements of the Pharmaceutical Industry that will allow Inotiv to maintain the level of accuracy and completeness required by regulatory, scientific and client standards. Ensure 100% review of data and tables for scientific integrity, accuracy and completeness. Ensure processes (an associated materials as for example standard checklists) are prepared, approved and used to ensure consistency during review of data. These processes will include but not be limited to: Review of all types of bioanalytical studies including endogenous and large molecule assays. Application of scientific and regulatory concepts to studies that do not fit standard bioanalytical protocol/processes. Review of chromatograms for proper peak integration. Review of instrument parameters and system suitability requirements per SAP/SOPs. Reconciliation of sample identity. Review sample receipt shipments. Ensure that appropriate documentation accompanies all data such that study can be reconstructed. Review of entries in laboratory notebooks and PDS Provide guiding principles and training on the purview of data to ensure integrity to Data Reviewers and other Inotiv scientists. Provide Inotiv staff guidance on SOP and documentation requirements. Provide critical evaluation of data review processes to improve efficiency and add value. Ensure sufficient stability has been verified to support the result for each sample analyzed. Ensure that appropriate federal regulations, study plans, and local SOPs governing studies were applied correctly. Maintain confidential information. Interact with the community and employees. Support and participate in other company initiatives as directed by senior management. Perform other duties as assigned.

Requirements

HPLC and GXP knowledge.
Familiar with Microsoft Office Excel and capable of learning new software packages.
Excellent problem-solving and organizational skills and the ability to multi-task.
Excellent oral and written communication skills.
Ability to use a personal computer to write reports and verify calculations.
Ability to comprehend and apply applicable government regulations (e.g. GXP, OECD).
Know and understand applicable national and state regulations, with the ability to apply these practices daily.
Working knowledge of and ability to adhere to HIPAA regulations.
Ability to adhere to all safety regulations and procedures.
Ability to interact with scientific staff at all levels.

Responsibilities

Coordinate all Data Review day to day activities
Develop processes adequate to the regulatory requirements of the Pharmaceutical Industry that will allow Inotiv to maintain the level of accuracy and completeness required by regulatory, scientific and client standards.
Ensure 100% review of data and tables for scientific integrity, accuracy and completeness.
Ensure processes (an associated materials as for example standard checklists) are prepared, approved and used to ensure consistency during review of data.
Review of all types of bioanalytical studies including endogenous and large molecule assays.
Application of scientific and regulatory concepts to studies that do not fit standard bioanalytical protocol/processes.
Review of chromatograms for proper peak integration.
Review of instrument parameters and system suitability requirements per SAP/SOPs.
Reconciliation of sample identity.
Review sample receipt shipments.
Ensure that appropriate documentation accompanies all data such that study can be reconstructed.
Review of entries in laboratory notebooks and PDS
Provide guiding principles and training on the purview of data to ensure integrity to Data Reviewers and other Inotiv scientists.
Provide Inotiv staff guidance on SOP and documentation requirements.
Provide critical evaluation of data review processes to improve efficiency and add value.
Ensure sufficient stability has been verified to support the result for each sample analyzed.
Ensure that appropriate federal regulations, study plans, and local SOPs governing studies were applied correctly.
Maintain confidential information.
Interact with the community and employees.
Support and participate in other company initiatives as directed by senior management.
Perform other duties as assigned.