QA Specialist I - Document Control

Hiring organization: Charles River Laboratories

Job posted: 2025-09-22

Valid through: 2035-09-22

Locations:

United States - Rockville

Experience requirements: 2-5 years experience

Education requirements: Bachelor's Degree

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

The QA Specialist I - Document Control is responsible for managing all controlled GMP documentation in compliance with internal procedures and policies, as well as regulatory requirements. The QA Specialist I establishes and maintains a system for the archival, retrieval, retention, and destruction of controlled documentation.

Key Responsibilities and Duties:

Serve as the second level approver for controlled documents for verifying if documents meet the internal document template requirements
Issue, review, reconcile, and file Batch Production Records in a timely manner
Issue, reconcile, and file logbooks in a timely manner
Issue approved forms (as required) in a timely manner
Maintains document templates, project tracking logs, and databases through standard electronic formats
Scans, uploads, and archives completed and reviewed controlled documents that are identified to be retained by QA in their appropriate locations
Responsible for supporting client and regulatory audits
Contributes to the overall management of client specific documentation
Monitors retention periods for controlled documentation and communicates with clients for documents reaching their retention period as defined in the Quality Agreement
Continuous reviews of all systems and procedures (SOPs) for efficiency and regulatory compliance improvements
Provide technical assistance throughout the document initiation, review, and approval process
Distribute approved documentation to appropriate personnel, track receipt of documentation, and maintain distribution matrices
Train personnel in document control/EDMS practices
Participates in continuous improvement initiatives within scope of work
Coordinates off site archival activities including interaction with off-site archive facilities for data storage and retrieval, as required
Ensure the Document Control room is in order
Assist in compiling Document Control performance metrics
Format Word documents

Job Qualifications

Bachelor's degree required
Minimum 2+ years of relevant experience in a similar position
Experience in managing paper based and electronic based document management systems in commercial pharmaceutical/ biopharmaceutical manufacturing and GMP environment
Experience in electronic document management systems. Experience in Trackwise is preferable
Strong verbal and written communication skills as well as technical writing and documentation skills
Strong organizational skills; able to prioritize and manage through complex processes/projects
Ability to perform and complete task independently
Knowledge of Microsoft suite (Word, Excel, Access, Vizio and PowerPoint)
Ability to follow instructions and Standard Operating Procedures
Ability to maintain a pleasant, approachable demeanor and communicate with professionalism
Ability to work onsite daily

Compensation Data

The pay range for this position is $65,000 - $75,000 USD per year. Please note that salaries vary within the range based on factors including experience, skills, education, certifications, and location.

About Charles River’s CDMO Services

With over 20 years of experience and industry-leading expertise, Charles River’s cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities—including plasmid DNA, viral vector, and cell therapy manufacturing—enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs.

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 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.

For more information, please visit www.criver.com.

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