Description

The Quality Control and Report Coordinator Level I position is responsible for the review, Quality Check, and organization of all Study data that is manually and electronically collected. They will thoroughly inspect the data for consistency, completeness, and compliance to the Study Protocol, Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), and other applicable regulations. Level I will also assist in compilation and generation of this collected data into necessary Data Tables, as needed.

Location: Onsite in Evansville / Mt. Vernon, IN
Schedule: Monday–Friday | 7:00 AM–3:30 PM

Pay: Starts at $19 - $22 / hour + full benefits within 30 days

Position Responsibilities:

Perform a thorough review/Quality Check of raw data and electronically entered information within the Database (Provantis or Ascentos) for consistency, completeness, accuracy and compliance with Protocol, SOPs, guidelines and regulations

Verify and address applicable findings from raw data or LIMS and coordinate responses from the appropriate personnel

Review Study Protocols, Amendments, schedules, and calendars

Understand, apply, and maintain adherence to GLP regulations, SOPs and Study Protocols and Amendments

Collate and organize raw data records within Study binders

Understand the purpose and procedure of all raw data forms

Generate and access information needed within appropriate Database (Provantis or Ascentos)

Efficiently and accurately generate Data Tables within the appropriate Database (Provantis or Ascentos), as needed

Upon request from the Histology Department and/or other personnel, compile Data Tables with information that has yet to be thoroughly reviewed or Quality Checked, which will subsequently be viewed by Pathologists.

Prepare the appropriate corresponding Table and/or Appendix key pages, as needed by Clinical Pathology

Assist with maintenance, review/Quality Check, filing and other processes pertaining to Room Maintenance Logs, Animal Data Collection Logs, and other Facility Records

Maintain a strong and positive working relationship with all departments.

Participate in Study initiation meetings

Perform other duties as assigned by Supervisor or appropriate personnel

Position Requirements:

Preferred Education and Experience

Associate’s Degree or higher in related sciences and/or up to a year of experience in research as a Laboratory Animal Technician or Quality Assurance/Quality Control

Tools, Equipment, & Other Resources Used

Various software applications sustained by a WindowsTM Microsoft platform (Excel, Word, PowerPoint, etc.), and Adobe Acrobat – Portable Document Formatting (PDF)

Enterprise Service Management (ESM), Master Control, Watson Laboratory Information Management System (LIMS), Projects Database System (PDS), Provantis, Ascentos, and other Databases

Microsoft Access (Outlook, Teams, Dynamics365, etc.)

Performance Requirements:

General Abilities

Ability to follow strict timelines

Ability to demonstrate strong organizational skills

Ability to pay close attention to detail

Ability to perform accurate, concise documentation and accurately proofread documents or data

Ability to work with critical reporting software systems (Microsoft Word, Excel, Adobe PDF, Provantis, Ascentos, etc.) and scanned documents and image files

Ability to interact respectfully and professionally

Ability to adhere to the SOPs and guidelines that protect the integrity of confidential information

Physical Activity

This position will require frequent sitting, screen/monitor use and studious activities for extended periods of time

May require additional hours/overtime

May require at times reaching while sitting/standing, walking, standing, carrying, lifting (max. 20 lbs.), gripping and twisting hand movements, finger control and other general repetitive motions and may require ability to walk over rough terrain

#LI-Onsite

#LI-MP1

*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.

Quality Control Reports Coordinator I

Description

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