Job Summary

We are seeking an experienced Lead Archivist for the Archives & Document Management team in Mattawan, MI.

The Lead Archivist is responsible for the efficient and effective execution of day-to-day operations of the Archives areas and that includes related programs, procedures, and as well as assisting with policy recommendations as needed. The Lead Archivist is responsible for verifying that the department follows federal regulations in regard to the Archived material. When unavailable, a member of management over the Lead Archivist may function as Lead Archivist, as necessary.

ESSENTIAL FUNCTIONS:

• Efficiently perform and document all procedures, materials and results in compliance with applicable regulatory standards as applicable (protocols, methods, SOPs, etc.)
• Ensure that all electronic and paper raw data, documentation, protocols, final reports, samples, and specimens collected from a study are retained in accordance with protocol and GXP regulations.
• Verify daily tasks of the department follow company Standard Operating Procedures (SOPs) and are compliant with government regulations
• May assist with performing department procedures
• Demonstrate effective communication skills through informal discussions with peers, supervisor, and team
• Independently identify and lead process improvement initiatives
• Assist with training of new staff members for all functions as needed
• Independently execute the completion of quality observations and investigations as needed
• Manage and perform administrator functions or the archival system, as needed
• Independently manage the resolution of data discrepancies involving documentation compared to Standard Operating Procedures, protocols, and regulations interacting with appropriate personnel, Sponsors and external sites as needed
• Independently function as a liaison with active communication between SD/PI/BM, Sponsors, CRL and third-party laboratories
• Provide functional oversight to staff in the absence of direct management
• Assist management in scheduling and task assignment as requested with minimal oversight
• Perform all other related duties as assigned

The pay for this position is $30/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

• HS/GED/Associate's degree with 6 years of relevant experience. Bachelor's degree (BA/BS) in a relevant field with 3-5 years of experience
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
• Ability to communicate verbally and in writing at all levels inside and outside the organization
• Basic familiarity with Microsoft Office Suite
• Computer skills, commensurate with Essential Functions, including the ability to learn a validated system
• Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts; sometimes on short notice
• Ability to work under specific time constraints

Competencies