Laboratory Application Specialist

Frontage Laboratories•Exton, PA

2d•Onsite

About The Position

This role supports lab operations and studies in a regulated (GLP/GCLP) research environment. Key responsibilities include documentation and data archival, sample handling, and other activities to support studies. The position supports project PIs (principal investigator) with documentation and coordination tasks, sample handling, ensuring compliance with GLP/GCLP standards and efficient study progression from setup to completion.

Requirements

Bachelor’s degree in Life Sciences, Biology, Chemistry, Biochemistry, or a related scientific discipline.
0–3 years of experience in lab assistant, document management, or records management (preferably in a regulated industry such as pharmaceutical, biotech, or CRO).
Experience with document control systems (e.g., SharePoint, Documentum, or similar).
Strong organizational and time management abilities with attention to detail.
Excellent communication and interpersonal skills.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
Analytical mindset with focus on process accuracy and compliance.

Nice To Haves

Familiarity with regulatory documentation standards (e.g., GxP, GLP) preferred.
Experience in a laboratory, clinical, or regulatory documentation setting.
Knowledge of long-term data retention and archival best practices.
Familiarity with electronic archiving systems and metadata management.

Responsibilities

Assist in daily laboratory activities such as sample management, labeling, preparation, and storage.
Maintain laboratory supplies, reagents, and consumables inventory to support ongoing projects.
Support instrument setup, calibration, and routine maintenance under supervision.
Support study PIs with project documentation and study setup tasks.
Assist in compiling data summaries, study logs, and project documents and reports.
Assist and maintain study records, worksheets, and study files according to SOPs.
Ensure all documents are reviewed, signed, and filed accurately.
Support document archival and retrieval activities per GLP/GCLP and company retention requirements.
Assist with electronic document uploads and metadata entry in LIMS or document management systems.
Follow all company SOPs, GLP/GCLP requirements, and data integrity standards.
Identify opportunities to improve relative workflows or documentation processes.
Support implementation of digital tools for study tracking or data management.
Participate in cross-functional process improvement initiatives.