Quality Systems Specialist II

Quality Systems Specialist II Req ID #:  213805 Location: 

Memphis, TN, US, 38118 Memphis, TN, US, 38118 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.

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.   

  Job Summary Support and maintenance of the quality system to include document control and facilitation of systems. To ensure a culture of compliance throughout the facility and performs all responsibilities in accordance with company policies, procedures, and federal regulations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

•Responsible for day-to-day management of the nonconformance (NC) process.

1.Check QA Drop Bin for new NCs, Review/Route Non-Conformances

2.Daily send out Triage Agenda prior to meeting, Lead NC Triage Meetings and Triage Summary email after meeting

3.Add new NCs to Tracker Log after Triage Meeting, Update NC Tracker before leaving

4.Scan & Save Closed NCs to W Drive

5.Send daily NC closure email before leaving

6.Update comments/magnets/dates on NC board, Update Board w/ NC Closures for the week

7.Update Client Priority List with NCs prior to Client Priority Meeting, Attend Client Priority Meeting9:00 & scan closed Client NCs to BOX before leaving

8.File all NCs/Attachments in Binder/File location

9.Provides daily nonconformance management for site metrics

10.Maintains the Nonconformance spreadsheet/tracker

11.Maintains the Nonconformance program SOPs

•NC Alignment on TUES/THUR

•Complete Master Control Tasks / Training

•Attend Work Center Team Board 8:30

•Update warehouse boards throughout the day

•Update WCT Board

•Updates the Quality Performance Boards daily

•Works with the Quality Compliance team to ensure all cross functional items are aligned

•Participates in continuous improvements to applicable Compliance Group Opportunities.

•All additional duties assigned by Quality Systems Manager Job Qualifications  

•BS/BA Life Sciences or related field

•Minimum of 1-year GMP related experience in biopharmaceutical/pharmaceutical or related industry.

•Experience with GMP regulatory requirements.

•Excellent written and verbal communication skills.

•Ability to prioritize daily activities to meet client needs on time of established timelines in a fast-paced environment.

•Ability to monitor and report on assigned tasks, goals, and objectives.

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 Biologics Testing Solutions

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. Offering 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.  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 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, or 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 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: Memphis

Job Segment: Pharmaceutical, Laboratory, Facilities, Document Control, Quality Assurance, Science, Operations, Administrative, Technology