Senior QA Specialist - Operations

Req ID #:  215850

Rockville, MD, US, 20850 Rockville, MD, US, 20850

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.


IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

Job Summary


The Senior QA Specialist is responsible to ensure that production process is client focused, results oriented, performance driven, and in compliance with all applicable internal and external requirements. The Senior QA Specialist will compile the batch record review records and batch disposition documents required for GMP operation on timely basis. 


This includes but is not limited to the following:


•    Provide QA oversight and support to client projects while working closely with QA Management to ensure QA support for GMP operations for the manufacture of master/working cell banks, bulk drug substance, plasmid products and/or final drug product used for human consumption.
•    Supports Manufacturing and quality control departments in performing, and documenting deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and identifying/implementing effective corrective and preventive actions (CAPAs).
•    Track and evaluate any non-conformances that occur during the manufacture of drug product and evaluate change controls as they impact the project.
•    Reviews deviation investigation reports for accuracy and adequacy of root cause analysis and CAPA identification.
•    Perform audits and/ or walkthrough of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.
•    Reviews executed batch production records and associated supporting documentation including logbooks, QC test reports, Environmental monitoring reports, cleaning records, etc.
•    Compiles batch disposition documentation timely for the final disposition of finished products.
•    Performs QA on the floor activities supporting client projects, including line clearance and room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.
•    Supports raw materials review and disposition following approved internal procedure. 
•    Receives and issues Batch Production Records and labels to manufacturing departments by verifying the accuracy and completeness from QA Document Control.
•    Ensures SOPs are current and effective, and staff performs routine tasks according to SOP through direct observation.
•    Reviews quality control test reports related to the execution of the batch processing.
•    Conduct training for QA and cross-functional team members as required.  
•    Drive continuous improvement and operational excellence culture through self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
•    Actively participates in all recruiting efforts to secure, onboard, and develop new staff members.
•    Evening and weekend hours may be needed to support production operations
•    Additional duties as assigned.

Job Qualifications


•    BS/ BA in life sciences or related fields. 
•    Minimum 7 years of experience in GMP related experience in biopharmaceutical/ pharmaceutical or related industry, with 3 years of direct experience in batch record review and batch disposition. 
•    Ability to multitask effectively. 
•    Previous knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines. 
•    Previous experience in TrackWise Digital and Pilgrim is a plus.
•    Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy. 
•    Strong verbal and written communication skills.
•    Strong organizational skills; able to prioritize and manage through complex processes/projects. 
•    Ability to work on complex problems of diverse scope and collect data to draw valid conclusions.
•    Ability to exercise sound judgment within defined procedures to determine appropriate actions for resolution of manufacturing or laboratory issues.
•    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). 
•    Ability to follow instructions and Standard Operating Procedures. 
•    Ability to always maintain a professional and pleasant demeanor. 


The pay range for this position is $97000-$110000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 

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 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.

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Nearest Major Market: Washington DC

Job Segment: Pharmaceutical, Quality Assurance, Laboratory, Operations Manager, Document Control, Science, Technology, Operations, Administrative