Technical Services Data Coordinator

Technical Services Data Coordinator Req ID #:  77672 Location: 

Charleston, SC, US, 29407 For nearly 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.

Summary:

Perform review of raw data and final reports for LAL contract testing assays, RSE/CSE standardizations and other data generated in the Technical Service laboratory. Process product returns and complaints, which includes collaboration with Technical Support, Customer Service, Production, Quality Assurance and customers. Initiate exceptions when required. Process documentation to assure accuracy and compliance with current Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP) and policies. Responsible for collecting and reporting of metrics associated with Technical Service activities and responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Review/update SOPs, protocols and other controlled documents for Technical Service with all pertinent GMP regulations and internal policies. Review contract testing according to applicable testing procedures. Review testing related to LAL RSE/CSE determination. Create Certificates of Analysis. Post certificates after approval to appropriate portals. Initiate and complete documentation associated with exceptions generated by Technical Service. Assist in training as required. May participate in inspections and audits. Responsible for assisting with and processing product returns and customer complaints. Compilation as well as presentation of metrics for processes associated with Technical Service such as contract testing, complaints, RSE/CSE testing, Service Cloud, quality management review sessions, complaint trending meetings, etc. for management on designated frequencies. Perform all other related duties as assigned

QUALIFICATIONS:

Education: Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.

Experience: 2 years related experience in areas such as quality systems, data review, metrics collection and reporting, in a GMP/GLP environment. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

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

Nearest Major Market: Charleston South Carolina

Nearest Secondary Market: South Carolina

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