Quality Control Reports Coordinator I

About the role

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.

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

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
• 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.)

Qualifications

• 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

Benefits

• Health and dental coverage
• Short- and long-term disability
• Paid time off
• Paid parental leave
• 401K

Schedule

First Shift - On-site Position