Quality Systems Specialist 2

Quality Systems Specialist 2 Req ID #:  169088 Location: 

Charleston, SC, US, 29407 For 70 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 We are seeking a Quality Systems Specialist 2 for our Microbial Solutions site located in Charleston, SC.  

Responsible for assisting / performing facility and / or process audits to assure compliance with the current Good Manufacturing Practice (cGMP) and Standard Operating Procedures (SOP).  Responsible for supporting preliminary reviews of local quality metrics from the Quality Management System (QMS).  Understand the voice of the customer and make recommendations to the Quality Systems Program Manager. Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management. Approximately 15% of this role’s responsibilities are customer-facing (e.g. customer audit participation and correspondences via email and telephone).

The following are the job duties & responsibilities related to the Quality Systems Specialist 2: 

•    Perform compliance assessments of site and cross-site quality systems (process inspections/facility inspections/equipment and record review 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.

•    Support corporate compliance assessments/mock-agency inspections of other Charles River sites.

•    Coordinate and facilitate site-wide cGMP training sessions, as developed and approved by senior Quality Systems team members.

•    May provide support during regulatory inspections, as requested.

•    Perform internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems.

•    Perform facility and equipment records and logbook reviews.

•    Support or conduct process-based inspections as deemed necessary.

•    Assist in identification of any regulatory risk areas.

•    Maintain written and signed records of auditing activities.

•    Assist with analysis and collection of site Quality Metrics via QMS.

•    Assist with preparations for semi-annual 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.

•    May assist in training of Quality Assurance personnel with focus on QMS.

•    Support Client audits.

•    Provide timely responses to Customer inquiries to support their qualification / regulatory requests.

•    Perform all other related duties as assigned.

  Job Qualifications The following are the minimum qualifications related to the Quality Systems Specialist 2: 

  Education:   Bachelor’s degree (B.S. / B.A.) or equivalent, preferably in a life science. Experience:   Minimum of 3 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.

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 17,000 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. And in 2019, revenue increased to $2.62 billion.

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 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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.

Nearest Major Market: Charleston South Carolina

Nearest Secondary Market: South Carolina

Job Segment: Biotech, Pharmaceutical, Laboratory, Quality Assurance, Science, Research, Technology