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.
The Quality Specialist coordinates with Scientists and Scientific Writers to ensure accuracy and integrity is maintained in the data and reports. Responsible for reviewing, inspecting, and auditing study data and materials to ensure that applicable methods, protocols, and SOPs are followed and that all guidelines and regulations are met within the data and reports.
Essential Duties and Responsibilities
- Review study reports and other deliverables for accuracy of reporting against the raw data
- Review data, reports, and other deliverables for compliance with the protocol and applicable methods, SOPs, guidelines, and regulations
- Work with investigators and scientific writers to correct or address any defects discovered
- Provide metrics as necessary to supervisors and Management on defects found
- Provide miscellaneous, internal inspection/auditing services as requested
- Participate in the site Corrective Action Preventive Action (CAPA) and Continuous Quality Improvement (CQA) programs as requested
- Perform other duties as assigned
Skills and Abilities
- Detail oriented with outstanding organizational skills
- Excellent communication and interpersonal skills
- Ability to multi-task in a high energy environment/manage multiple projects concurrently
- Ability to interact and problem solve with scientific staff
- In-depth understanding of study specific services and general facility operations
- Thorough understanding of relevant regulations (e.g., GLP and GCP)
- Ability to work independently and as a team member
- Proficient in applicable computer applications including MS Office
- Interact with clients, other employees, and the community in a professional manner
- Effective organizational, written, and oral communication skills
- Ability to adhere to all company policies, safety regulations and procedures
- Maintain confidential information
- Support and participate in other company initiatives as directed
- Ability to read, write, speak, and understand English
- Demonstrate Inotiv Core Values and adhere to Code of Conduct
Education and Experience
- Bachelor’s degree or higher (life sciences preferred)
- Two years or more of relevant experience
- Equivalent combination of related education and required work experience will be considered with Management approval
Physical Activity and Working Conditions
- Work is normally performed in a typical interior office or laboratory environment
- Prolonged periods of sitting at a desk and working on a computer
- The noise level is usually moderate
- Requires moderate physical activity with frequent talking, standing, walking and repetitive movement of hands and fingers, reaching and lifting 10 -50 pounds.
- Use of PPE (Personal Protection Equipment) when required (i.e., able to wear latex or nitrile gloves, dust mask or respirator, and safety glasses as required)
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 participation with company match, etc.
Inotiv is a proud equal opportunity employer and an E-Verify employer.