Laboratory Application Specialist-Large Molecule

Laboratory Application Specialist-Large Molecule - a role that is to support lab operational and studies in a regulated (GLP/GCLP) research environment, including but not limited to documentation and data archival, sample handling, and other activities to support the studies. This role will support 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., * 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.
• Other assigned tasks

1. Study Coordination and Documents/Data Archival

• 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.

1. Continuous Improvement

• 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.

• 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).
• Familiarity with regulatory documentation standards (e.g., GxP, GLP) preferred.

Skills:

• 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.

Core Competencies:

• Accountability and ownership
• Process-oriented and detail-focused
• Team collaboration and cross-functional coordination
• Data and document integrity awareness
• Problem-solving and initiative-taking

Preferred Qualifications (optional):

• 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.

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.