The Project Coordinator will maintain, schedule and validate electronic data capture software and will be responsible for the creation, editing, routing, revision and approval of Inotiv corporate documentation and standard operating procedures (SOPs).

LIMS Specialist

Maintain the organization and schedule of the electronic data capture systems
• Catalogue materials, manage records as required by FDA GLPs
• Responsible for initiation, programming study design, and maintaining multiple software programs such as Pristima, Provantis, Smartsheets and Master Control
• Schedule study activities for all studies in the electronic data capture software
• Responsible for interfacing the electronic data capture software with equipment and maintaining the system settings to maximize consistency and efficiency
• Responsible for supporting validation of electronic software systems
• Maintains user lists for all electronic software programs, including but not limited to new user creation, user deactivation, and role development
• Develops and delivers employee training on software systems
• Negotiates and manages software systems contracts and user licenses
• Regularly interacts and observes data capture to ensure quality and consistency of use
• Participates in cross-site teams for software programs development

Quality System Document Coordinator (QSDC), Master Control Software

• Coordinate system collaboration and approval of documents
• Delegate electronic signatures to employees
• Review, monitor, coordinate, and launch electronic training of quality documents to employees
• Assist and collaborate with users on the system functions
• Update SOPs, QPDs, SAPs, TECH.NOTES, forms monthly and as needed

Administration

• Review standard operating procedures and policies

System Administrator, Calibration Manager Software (Cal Man)

• Maintain, modify, update equipment inventory
• Schedule equipment calibrations and verifications
• Assign identification labels and document new equipment
• Support users navigating Cal Man

Education and experience

• Minimum B.S./B.A in scientific related field.
• Knowledge of GLP regulations in a medical device/life sciences environment.
• One to three years of work experience in a CRO environment.
• Equivalent combination of related education and required work experience will be considered.

Critical Success Factors

• Good organizational skills.
• Ability to effectively use Microsoft Word, Excel, Windows NT.
• Ability to comprehend and apply GLP.
• Ability to learn and utilize various software (e.g. Pristima, Provantis, Master Control and Smartsheets)

Working Conditions and Physical Requirements

General

• Ability to read, write, speak and understand English
• Ability to read, write and understand oral and/or written instructions

Physical Activity

• This position will require frequent walking, sitting and/or standing for extended periods of time, carrying, heavy lifting (max 50 pounds), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions.
• Able to wear latex gloves, dust musk or respirator, and safety glasses as required.
• Ability to read and understand applicable materials
• Manual dexterity to operate laboratory equipment and calculator/computer

Working Conditions

• Able to wear latex or nitrile gloves, dust mask and/or respirator, and safety glasses as required.
• May be exposed to animal dander and/or material associated with animal husbandry
• The noise level is usually moderate

Tools, Equipment, & Other Resources Used

• Various software applications sustained by a WindowsTM platform. (Excel, Word, PowerPoint, etc.)
• Various software applications. (Pristima, Provantis, Master Control, Smartsheets, etc.)

*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 is $26.00-$34.00/hr and 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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