Quality Systems Specialist

Job description

For nearly 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.

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 participate in identifying recommendations to the Quality Management.

Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management.

Approximately 5% 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.
• 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.
• Participate in the process for identifying recommendations to Operations and Quality Management for improvements in auditing of quality systems.
• Participate in the preparation of study and QA files in preparation for sponsor site visits and regulatory inspections.
  
  May participate in the support of client site visits.
• Assist in the development of recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings.
• Participate in the execution of 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.
• Participate in the performance of 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.
• Perform facility and equipment records and logbook reviews.
• Where appropriate, approve customer test reports and participate in reagent release activities to support laboratory operations.
• Assist in correction of any regulatory risk areas as identified by Senior Quality Systems team members.
• Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.
• Assist with analysis and collection of site Quality Metrics via QMS.
• Assist with preparations for Quality Management Review (QMR).
• Participate in the execution of identified process-improvement for dashboard analysis and analyze metric data for QMS.
• Participate in execution of Quality Assurance projects.
• Assist with providing basic regulatory training to operations personnel.
• Provide timely responses to Customer inquiries to support their qualification / regulatory requests.
• Perform all other related duties as assigned.

About Microbial Solutions
Our Microbial Solutions business group has a  comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry.

We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

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.

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.

Required Skill Profession

Business Operations Specialists