Document Control Specialist I

Charles River Labs; Malvern (Chester County); On-site; USD 60,000 - 80,000; Full time

Job summary

Charles River Labs is seeking a motivated candidate to support their Quality Enterprise Systems group. This role involves managing Standard Operating Procedures and ensuring compliance with document management standards. The ideal candidate will have a high school diploma and relevant experience, demonstrating strong attention to detail and organizational skills.

Benefits

401K

Paid time off

Health and wellness coverage

Employee and family wellbeing support programs

Qualifications

• One to 2 years related experience in data entry and document management.
• Basic knowledge of medical terminology preferred.

Responsibilities

• Coordinate the revision process of Standard Operating Procedures (SOPs).
• Serve as local system administrator for CROSS and QMS.
• Manage daily flow of controlled documents.

Skills

Attention to detail

Organization

Prioritization

Basic computer skills

Education

High school diploma or General Education Degree (G.E.D.)

Tools

Document Management System

Word processing software

Database record keeping software

Job description

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

Provide support to the Quality Enterprise Systems group applications, the Charles River Online SOP System (CROSS) and the Quality Management System (QMS). May provide support on harmonized business segment projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Coordinate the revision process of Standard Operating Procedures (SOPs), forms and other controlled documents. Assist in organizing QA records and archiving.
• Maintain historical files for SOPs and forms.
• Assure that site document management strategies and regulatory requirements for electronic documents are upheld.
• Enter, update and edit controlled documents and coordinate requirements for new documents with internal customers.
• Maintain the Master Schedule.
• Serve as the back-up system administrator for CROSS and QMS serving all Charles River operations which includes responsibilities for establishing user accounts, assigning roles and access and privileges.
• Assist in QA auditors with QA record archiving and administrative support.
• Manage the daily flow and final release of controlled documents through the document management system.
• Serve as the local system administrator for the Document Management System known as Charles River Online SOP System (CROSS) including responsibility for establishing user accounts and assigning roles and access and privileges.
• Perform all other related duties as assigned.

Job Qualifications

• Education: High school diploma or General Education Degree (G.E.D.)
• Experience: One to 2 years related experience in data entry and document management. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None
• Other: Basic computer skills required. Computer literacy in word processing and database record keeping experience required. Basic knowledge of medical terminology preferred. Attention to detail and the ability to organize and prioritize work and meet deadlines required.

Compensation Data

The pay rate for this role is $24.00 per hour. 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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 [e-mail]. 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 www.criver.com.