Quality Control Coordinator, Report Writing

Quality Control Coordinator, Report Writing Req ID #:  152915 Location: 

Ashland, OH, US, 44805 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 currently seeking a Quality Control Coordinator for our Safety Assessment group site located in Ashland Ohio.

Responsible for advanced quality control of study reports and report tables as well as assistance with special projects to facilitate study/project quality and timeliness.  Responsibilities include review of data in collaboration with QC and QA personnel, assisting with special projects and generation of reports for assigned studies in accordance with Good Laboratory Practice Regulations and Standard Operating Procedures with little or no supervision/instruction.  Fulfills a leadership role in the department, including assisting in the training of other personnel.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

•    Review protocols (nonstandard statistical analysis requirements, data requiring manual table generation, electronic reporting requirements, etc.) 

•    Review and monitor RTSS data correction requests and quality assurance data audits

•    Assist with review of reports, including text, tables, and figures

•    Identify problem areas with data and communicate to appropriate QC/QA personnel and supervisors/managers

•    Collaborate with personnel in other departments to identify and rectify QC issues

•    Assist with historical control data verification and/or database management

•    Provide support for software validation and change control

•    Training of personnel

•    Assist with the analysis, development, and enhancement of processes, procedures, and techniques

•    Developing or revising systems to increase departmental and company efficiency

•    Maintain appropriate departmental metrics

•    Assist report coordinators, report administrators, study analysts, supervisors, and managers

•    Act as primary point of contact for assigned projects and/or processes/procedures

•    Regular and punctual attendance

•    Comply with all Charles River policies and procedures

•    Follow all safety rules and regulations

•    Adhere to all environmental regulations

•    Attend and participate in all required training sessions

•    Work as a team member

•    Ability to understand and follow oral and written instructions

•    Other duties as assigned by departmental management Job Qualifications •    Education:  BA/BS Degree in a natural science field

•    Experience: 2-3 years experience at Study Analyst level, or equivalent experience in a QC role in another department desirable but not required

•    Other:  Attention to detail, excellent interpersonal and organizational skills, proficiency with use of computer system, personal computer literacy, familiarity with quality assurance practices and the ability to communicate effectively at several levels of an organization.  Experience with good laboratory practices considered desirable.  Ability to interact effectively with diverse personalities and ethnic backgrounds is essential.

Vaccine Mandate

Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 

Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

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 18,000 employees within 100 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 supported the development of >80% of the drugs approved by the FDA for the past 3 years.

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, 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: Cleveland

Nearest Secondary Market: Mansfield

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