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Archives - Lead Archivist

Charles River Laboratories International Inc (CRL)

Mattawan, MI, US, 49071

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

Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.

About Safety Assessment Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

Job posted: 2023-04-03

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