Quality System Specialist II

Req ID:  188954
Location: 

Dublin, IE, D09


At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families. 

 

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career. 

 

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

 

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.   
 

BASIC SUMMARY:

 

Responsible for assisting / performing facility, process, vendor and local validation activities to assure compliance with applicable federal, state, and local regulations as well as corporate policies,  Good Manufacturing Practice (GMP), applicable ISO requirements and Standard Operating Procedures (SOP).  Understand the voice of the customer and make recommendations to the Quality Management. Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management. Approximately 10% of this role’s responsibilities are customer-facing (e.g. customer audit participation and correspondences via email and telephone).

 

ESSENITAL DUTIES AND RESPONSIBILITIES:

 

  • Assure Charles River’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions.  Communicate all identified compliance and quality risks to supervisor.
  • Perform compliance assessments of site and cross-site Quality Systems (process inspections/facility inspections/equipment and record review/computer validation activities; and/or training records) including review of client audit observations. 
  • Provide recommendations to Operations and Quality Management for improvements in auditing of quality systems based on knowledge and understanding of current regulatory inspection guidance and internal trends.
  • Assist in tracking of QA audits, inspections and procedures, as applicable.
  • Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections.  May host client site visits.
  • Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.
  • Support the execution of corporate compliance assessments/mock-agency inspections of other Charles River sites.
  • Coordinate and facilitate site-wide applicable regulations or standards (ISO/GLP/GMP)  training sessions, as developed and approved by senior Quality Systems team members.
  • Participate in the preparation of support during regulatory inspections, as required.
  • Independently perform internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems. 
  • 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.
  • Review SOPs, protocols/batch records, reports, quality and regulated records (e.g. deviations, change controls, or CAPA) involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
  • Perform facility and equipment records and logbook reviews.
  • Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations.
  • Support meeting the review requirements for Customer or Supplier related Quality Agreements
  • Support or conduct process based inspections as deemed necessary.
  • Assist in identification of any regulatory risk areas.
  • Assist with reporting, analysis and collection of site Quality Metrics via QMS.
  • Assist with preparations for Quality Management Review (QMR) and support during the QMR.
  • Provide process-improvement recommendations for dashboard analysis and analyze metric data for QMS.
  • Participate in coordination of Quality Assurance projects.
  • Assist with providing basic regulatory training to QA and operations personnel.
  • Provide timely responses to Customer inquiries to support their qualification / regulatory requests.
  • Perform all other related duties as assigned.

 

QUALIFICATIONS:

 

  • Education:   Bachelor’s degree (B.S. / B.A.) or equivalent, preferably in a life science.
  • Experience:   Minimum of 5 years in a Quality Assurance role. 
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Other:  Some experience with Microsoft Office® applications.  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.

 

PHYSICAL DEMANDS:

 

  • 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.

 

WORK ENVIRONMENT:

  • 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.

 

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 Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. 
 

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 90 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 ~85% of the drugs approved by the FDA in 2021.
 

At Charles River Laboratories, we recognize and recruit all talent. We are a company committed to the principle of diversity and inclusion and work daily in this direction.

 

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