Supervisor Document Control

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.

Job Summary

The Supervisor Document Control will lead the Document Control team supporting the issuance, reconciliation, and archival of all controlled documents. The Supervisor Document Control provides coordination, leadership, and technical expertise for the filing issuance requests, review of materials to be reconciled, and storage/archival of controlled documents for the Memphis facility. The role is responsible for ensuring that these activities are timely, efficient and productive while adhering to regulatory requirements and operational and quality parameters.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversee the coordination and maintainenance of both electronic and hard copy records in compliance with current Good Manufacturing Practices (cGMP) and site quality approved procedures

• Lead and develop a team through coaching, mentor, and establishing goals and monitoring progress

• Maintain an organized filing system for both hard copies and electronic files including onsite and offsite archiving program

• Ensure that documentation and records are indexed, filed, archived, retrievable and issued, consistent with procedures and policies

• Provide cross-functional support associated with document coordination, record coordination and control, data entry and reports, and general office support

• Review/approve workflows in the electronic document management system(s)

• Provide guidance to system users on change request generation and document formatting

• Organize and coordinate documents and labels to be issued to production based upon standard operating procedures and established production schedule and timelines

• Assist in the creation of draft documents required for Electronic Document Management System

• Complete documentation of activities per Good Documentation Practices and site quality approved procedures

• Tracks and stores all documents turned in to Document Control including but not limited to, Master Batch Records, Training files, Nonconformance files, CAPAs, etc.

Job Qualifications

• High School diploma or equivalent required; bachelors degree preferred

• Minimum 2 years of experience in a similar Biotechnology Document Control position.

• Experience leading people, preferred

• Excellent organizational (Records Management) and prioritization skills.

• Strong verbal and written communication skills as well as technical writing and documentation skills.

• Ability to organize and disseminate information efficiently and multi-task in a fast-paced environment,

• Organized, responsible, creative, pays attention to detail, multi-tasker.

• Knowledge of Microsoft suite (Word, Excel, Access, Vizio and PowerPoint).

• The ability to follow instructions and Standard Operating procedures.

The pay range for this position is $85,000 - $90,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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, or 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 ~~~. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit ~~~.

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