Sr. Quality Assurance Specialist

Req ID #:  215558

Oklahoma City, OK, US, 73102

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

Responsible for performing basic to highly complex auditing as it relates to validation, vendors, internal facility programs and process audits and providing regulatory support for training and client visits as well auditing of all study designs and data associated with a study to assure compliance with the applicable Good Manufacturing Practice Regulations (GMP) and laboratory Standard Operating Procedures (SOP). Responsible for recommending best practices, developing Quality Assurance auditing efficiencies, solutions, documentation and liaising with all relevant stakeholders.


  • Perform and/or oversee internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems.
  • Perform and/or oversee internal process audits at planned intervals to evaluate effective control and maintenance of site quality systems.
  • Develop and/or participate in the development of site facility and process-based inspection schedules.
  • Perform and/or oversee vendor audits at planned intervals to evaluate effective control and maintenance of site quality systems.
  • Develop, manage, and/or provide training to QA Auditors.
  • Oversee and/or participate in site GMP training program.
  • Perform and/or oversee auditing of validation packages.
  • Host and oversee all aspects of QA client visits.
  • Host or provide support for all aspects of regulatory/monitoring authority inspections.
  • Provide recommendations to Testing Facility and Quality Management for improvements of Quality Systems based on extensive knowledge and understanding of current regulatory inspection guidance and internal trends
  • Participation in site or multi-site QRM projects to ensure robust and value-added approach to facility and process inspection programs.
  • Perform the review and updating of departmental SOPs to reflect current practices
  • Take lead role in coordination of QA projects.
  • Ensure Data Integrity standards are effectively monitored.
  • Lead and participate in cross-site auditing support of quality system functions.
  • Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols, and corporate policies and procedures.
  • Review/approve SOPs, protocols reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
  • Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
  • Act as the technical QA subject matter expert, consult with operations site leadership and mentor more junior auditors.
  • Review QA auditing, vendor management, and quality systems practices to identify efficiencies and make recommendations to leadership
  • Perform all other related duties as assigned.

Job Qualifications


  • Education: Bachelor’s degree (B.S. /B.A.) or equivalent, preferably in a life science, Master’s degree is preferred.
  • Experience: Minimum of 12 years in a Quality Assurance role preferably in the life sciences field.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certifications/Licensure: Not required but desirable
  • Other: Experience with Microsoft Office® applications and spreadsheet/database programs such as Access and Excel. Position requires the individual to be able to communicate clearly, effectively and professionally; easily grasp instructions without follow-up; attention to detail and strong writing skills are essential. The ability to work independently and manage multiple projects is required.


  • Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
  • Must regularly communicate with employees/customers; must be able to exchange accurate information.
  • Must occasionally move about inside the office to access file cabinets, office machinery, etc.
  • May occasionally be required to wear protective clothing and equipment.


  • General office working conditions and/or laboratory/manufacturing areas.
  • The noise level in the work environment ranges from low to moderate.
  • May occasionally be required to work in tight or confined spaces.
  • May occasionally be exposed to high temperatures and humidity.


  • May require occasional domestic and/or international travel (up to 30%).

Compensation Data

The pay range for this position is $93,000/yr - $110,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.


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.
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.
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.
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.

About RightSource (Biologics Testing)

The biopharmaceutical industry is growing at an unprecedented pace which is simultaneously changing current testing methodologies. To keep up with the demand, we offer a flexible testing platform which can be deployed on-site at the client site to their exact needs. Our biologics testing a box…at the client site. RightSource is completely managed and operated using our quality management system, SOP’s, methods, and best practices. It’s as if you shipped your samples to an outsourced lab but walked down the hall instead.

Our Biologics Testing Solutions offers 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.  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. 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, 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

Nearest Major Market: Oklahoma City
Nearest Secondary Market: Oklahoma

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