GLP Archive Specialist: Records Management & Documentation

Kelly Science, Engineering, Technology & Telecom; Newark (DE); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid holidays

Job summary

Kelly Science & Clinical is seeking an Archive Specialist in Newark, DE to manage lab study records under GLP guidelines. You will organize, index, and securely store physical and electronic documents and support retrieval for audits and regulatory requests.

Ideal candidates have a background in records management in regulated environments, strong attention to detail, and proficiency with document management systems and MS Office. This role emphasizes compliance and precise documentation.

Qualifications

• Bachelor's degree or equivalent combination of education and relevant experience; four years of related experience may substitute for a degree.
• Knowledge of Good Laboratory Practice (GLP) standards.
• Experience in records management, document control, laboratory documentation, or a regulated environment preferred.
• Familiarity with SOPs, quality management systems, and compliance documentation.
• Strong organizational skills and exceptional attention to detail.
• Proficiency in Microsoft Office and Adobe applications.
• Ability to manage confidential information and maintain accurate records.
• Excellent communication, time management, and problem-solving skills.
• Ability to work independently while collaborating with cross-functional teams.

Responsibilities

• Maintain, organize, and track laboratory study records, including protocols, raw data, and other regulated documentation.
• Enter and update records in electronic inventory and document management systems.
• Scan, index, and upload documents into electronic databases.
• Coordinate the transfer of study records from laboratory and regulatory teams into archival storage.
• Maintain accurate records of document checkouts, retrievals, and storage locations.
• Ensure documentation and records management activities comply with GLP regulations and established SOPs.
• Assist with records review, reconciliation, cleanup, and organization projects.
• Respond to internal requests for archived documents and support timely records retrieval.
• Provide backup support for archive operations, including receiving study documentation, managing archive requests, and maintaining archive security.
• Support regulatory documentation requests and audit readiness activities.

Skills

Attention to detail

Organization

Communication

Problem-solving

MS Office

Adobe Acrobat

Confidential data

Independent work

Education

Bachelor's degree or equivalent

4 years experience in lieu of degree

Tools

EDMS

Archive inventory systems

Job description

Kelly Science & Clinical is seeking an Archive Specialist in Newark, DE to manage lab study records under GLP guidelines. You will organize, index, and securely store physical and electronic documents and support retrieval for audits and regulatory requests.

Ideal candidates have a background in records management in regulated environments, strong attention to detail, and proficiency with document management systems and MS Office. This role emphasizes compliance and precise documentation.