Quality Control Specialist- Report Generation

Corporate Responsibilities:

Adherence to laboratory health and safety
• Adherence to Standard Operating Procedures (SOPs)
• Adherence to applicable company policies and guidelines
• Adherence to federal and/or local regulations as applicable

Essential Position Responsibilities:

• Manage and lead the quality control process across all departments with a focus on high quality report generation. Review and/or implement processes across departments to improve quality control.
• Be familiar with and adhere to regulatory guidelines as applicable (GLPs, ICH, OECD, etc.)
• Ability to employ critical reporting software systems (MSWord, Excel, Provantis) and work with scanned document image files. Create tools to increase efficiencies, quality, and presentation of reports.
• Perform quality control reviews of study data, databases, raw data, records, data summaries, and reports to ensure accuracy, correctness and completeness.
• Verify findings and review raw data, consulting with departments regarding any abnormalities.
• Compile data tables and materials/methods for multiple toxicology reports and data packages, concurrently.
• Review study protocols and amendments, prepare reporting schedules, and participate in study meetings.
• Interact with toxicology staff and subcontractors to monitor quality control of critical phases of studies as needed, for compliance with protocol, SOPs and applicable regulations.
• Engage with Quality Assurance auditors in developing processes.
• Perform validation and implementation of software (new, upgrades, etc.) as necessary.

Additional Position Responsibilities:

• Assist in training of new TAs.
• SEND data review
• Perform other duties as assigned

Professional Responsibilities: (if applicable)

• Attend continuing education courses, as appropriate.

• BS/BA degree and/or at least 10 years of experience
• Excellent computer, communication and writing skills; ability to work independently.

Additional Requirements:

• Overtime and weekend work as required.
• Work may require the use of PPE (personal protective equipment)

*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.

Inotiv has been named a 2023 Top Workplace!

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.

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