Administrator, Document Control

QPS Holdings • Newark, DE

120d

About The Position

Incumbent performs various administrative duties with integrity and ensures all QPS records and business affairs assigned to them are kept in a confidential manner. Tasks assigned serve to ensure company records are kept controlled, organized, protected, and secured for internal and external compliance reviews. Incumbent serves as a Subject Matter Expert on respective document control tasks and, as qualified, may also conduct audits for professional growth and maximizing audit capacity.

Requirements

• High school diploma, college certificate, Associate's or Bachelor's degree.
• One (1) year working in a regulatory environment (GLP, GCP, or GMP).
• Proficient in Microsoft Outlook, Word, Excel, PowerPoint, and Adobe.

Responsibilities

• Maintain personal integrity and client confidentiality in all job aspects.
• Ensure QPS documents received to manage tasks are kept controlled, protected, and secured.
• Support working teams by retrieving and converting documents into digital format (e.g., PDF).
• Save digital documents to appropriate project folders using consistent file naming conventions.
• Perform quality control checks to ensure accurate, legible, and complete digital documents and folders.
• Maintain organized, current, and accurate files and folders (paper and electronic).
• Support QA Host to facilitate external audits and inspections (e.g., client, consultant, US FDA).
• Administer secure portal for external virtual reviewers (e.g., iDeals Virtual Data Room, Box.com).
• Correspond with client and Agency representatives in regards to fulfilling deliverable requests.
• Provide only authorized deliverables to support QPS Host in facilitating external reviewer requests.
• Prepare Master Schedule copy and redacts thereof per QA Host for external audits and inspections.
• Perform monthly Master Schedule tasks and provide statistics to QA management.
• Maintain current SOP binder set assigned to Quality Assurance.
• Perform year-end Quality Assurance administrative tasks to ensure QA records maintenance.
• Archive Quality Assurance records for secure historical retention and evidence of completed tasks.
• Travel to Newark, Delaware QPS facilities as needed to retrieve/return company documents.
• Attend training seminars as directed by line management.
• Keep current on policy and procedure reviews as directed by line management.
• Conduct QA system or study audits such as facility, process, suppliers, Employee Qualification Manuals, study-specific trace-back, deviation form reviews and processing, etc.
• Log work hours into company system (e.g., ADP) and obtain overtime pre-approval from management.
• Provide additional administrative tasks as supported or directed by management.

Benefits

• Great learning opportunities, especially for those new to the field.
• Structured Career Ladders that provide excellent growth based on personal aspirations.
• Bonuses and merit increases linked to individual, team and company performance.
• Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance.
• Park-like setting in Newark, Delaware.
• Internal committees designed with the needs and enjoyment of QPS employees in mind.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees