Supervisor Technical Writing
Charles River Laboratories International Inc (CRL)
Memphis, TN, US, 38118
Supervisor Technical Writing Req ID #: 180531 Location:
Memphis, TN, US, 38118 Memphis, TN, US, 38118 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.
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
Reporting to the Head of the Quality Engineering function the Supervisor(s) of Technical Writing will oversee technical writers, collect information, organize investigation processes and author standard operating procedure revisions (SOPs), “Phase II” Out of Specification Reports (OOS) , deviations, various protocols and reports. Interactions will be extensive within the company and also extend to external clients and collaboration partners for technical advice and consultation. The ideal individual will have a working understanding of good manufacturing practices and be able to comprehend manufacturing and laboratory processes, including needed contamination and cross-contamination controls as well as basic requirements for equipment and method qualification, as well as training. A good understanding of how to use rootcause analysis techniques for deviation and out-of-trend/out-of-specification investigations is also a requirement for the position. Technical writing skills are of critical importance. Directly supervised a team of Technical writers responsible for deviation investigations, CAPA project execution, Change Controls, Risk Assessments and SOP revision for all departments based on the needs of the Memphis organization. Oversees and author technical writers who author deviation investigations, including root cause analysis and CAPA development, in consultation with manufacturing and quality departments. Basic familiarity with applicable regulatory requirements concerning cGMP manufacturing and testing of human cells according to published regulatory requirements and guidances Responsible for working collaboratively with the Quality Operations, Quality Assurance, Validation, Manufacturing, Project Management, and both Quality Control units to meet company and client goals. Lead or assist with OOS, deviation investigations, and CAPA investigations and resolutions including conducting interviews, observing procedures, documenting the investigation and timeline. First level review of drafting of finished investigations or reports Tracking documents in the quality system to ensure timely completion according to the standard lead times set by CRL management Verifies own work and ensures the correct and timely implementation of all documentation. Checks format and compliance to company templates. Actively participates in an environment that fosters safety, quality and continuous improvement in cost and customer service Other duties as assigned. Job Qualifications Bachelor of Science or higher degree in biology (or a related) discipline, or equivalent experience in various roles Minimum five years of relevant experience; and/or training; or equivalent combination of education and experience. Experience leading investigations and continuous improvement efforts in a GMP /Pharmaceutical/Manufacturing environment is required. Proficient in all manner of computer system use, including but not limited to Microsoft Office Suite and electronic document management systems. Strong analytical, problem-solving, and project management skills. Prior experience with SOP, protocol, and report writing Excellent written and oral communication skills are essential. Must possess initiative to seek resolution to a problem and utilizes teamwork and good communication to collaborate on solutions
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.
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. Our main priority is the wellbeing, health, and safety of our people. We require proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition ([email protected]) so that information can be provided about the accommodation process at Charles River.
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 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 [email protected] 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, Technical Writer, CAPA, Recruiting, Laboratory, Science, Technology, Management, Human Resources
Similar CRA jobs
ETL Technical Advisor
Technical Proposal Specialist
Technical Analyst II, Informatics
Technical Trainer 2 - Toxicology
Field Service Supervisor
Senior Regulatory Affairs Associate / Consultant- Non/Clinical Writing
Clinical Technical Editor (FSP)
Seasonal Help - Invivo Sciences Technical Assistant Surgery 1
Medical Writing Manager
Field Service Technical Specialist 1
Analytical Group Supervisor
Qlik Technical Leader
Laboratory Technical Associate (1804038)
Sr Technical Product Manager
Sr. Accountant, Technical Accounting
Senior Technical Project Manager (Home-based) - IQVIA Biotech
Vice President, Technical - Clinical Regulatory Affairs
Supervisor Sample Management