Supervisor, Quality Control and Reports

• 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.

Skills and abilities

• 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.

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.