Quality Control Reports Coordinator I

Inotiv•Evansville, IN

41d•Onsite

About The Position

The Quality Control and Report Coordinator 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.

Requirements

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
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
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 50 lbs.), gripping and twisting hand movements, finger control and other general repetitive motions and may require ability to walk over rough terrain
Potential exposure to animal dander and/or material
Ability to work in an environment with mild/moderate noise level or distraction
Potential involvement with radiant/electrical energy, solvents, grease, oil, irritants, acids, bases, and other hazardous chemicals, electro-mechanical hazards, flammable materials and biohazards. Due to exposure to hazardous biological materials (which may include HIV positive specimens), immunization to diseases may be required
Mantoux TB test with negative result may be required
Maintenance of personal protection through the use of latex or nitrile gloves, dust mask and/or respirator, and safety glasses may be required

Nice To Haves

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.

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 the 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