Quality Control Reports Coordinator

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.

First Shift - On-site Position

Responsibilities and Duties:

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

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, Dynamics
365, etc.)Performance Requirements:
* Characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

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…