Technical Writer

Req ID #:  190040
Location: 

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

 

We are seeking a Technical Writer for our Cell Therapy Manufacturing Facility located in Memphis, TN.


Reporting to the Supervisor Technical Writer, this position will investigate and resolve manufacturing and laboratory deviations by collecting information, evaluating procedures and data, and performing root cause analysis. The position is responsible for authoring deviation investigations, standard operating procedures (SOPs), corrective and preventative actions (CAPAs), change controls, study protocols, and technical reports. Interactions will be extensive within the company and extends to other external clients and collaboration partners. 

The ideal individual will have a working understanding of cGMP biopharmaceutical manufacturing and associated quality control test methods. A good understanding of how to conduct root cause analysis (i.e., 6M) for deviation and out-of-trend/out-of-specification investigations is also a requirement for the position. Excellent technical writing skills are of critical importance.

 
The following are responsibilities related to the Technical Writer position:


•    Lead and/or assist with the investigation, impact assessment, and resolution of manufacturing deviations and Out of Specification (OOS) laboratory test results.
•    Responsible for collecting investigation information by conducting interviews, observing procedures, and collating process / laboratory data.
•    Perform statistical analysis including statistical process control trending and hypothesis testing as part of investigations.
•    Author finished investigations or reports according to established company templates.
•    Track documents in the quality system to ensure timely completion according to the standard lead times set by CRL management.
•    Attend scheduled weekly meetings to provide updates on deviation investigations, OOSs, CAPAs, and Change Controls.
•    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.
•    Perform other duties, as assigned.
 

Job Qualifications

 

The following are minimum qualifications related to the Technical Writer position:


•    Bachelor’s degree in a scientific field with pharmaceutical manufacturing, validation, or laboratory (research or quality control) experience preferred.
•    Minimum 1-2 years of related work experience preferred.
•    Prior experience with SOP, CAPA, Change Control, protocol, and/or report writing.
•    Understanding of manufacturing/laboratory investigations and the process of conducting them in a GMP environment.
•    Excellent written and oral communication skills with a thorough knowledge of grammar, spelling and punctuation.
•    Ability to perform detailed-oriented work with a high degree of accuracy under established deadlines.
•    Ability to analyze and resolve complex problems via root cause analysis techniques (e.g., 6M, 5 Why) to identify deviation root cause and make clear recommendations for solutions.
•    Must possess effective organizational and time management skills with the ability to multitask and work towards multiple priorities and goals.
•    Must be able to work independently but be able to identify problems proactively and know when to seek advice
•    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. 


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.  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 (crrecruitment_US@crl.com) 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 20,000 employees within 110 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 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, 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

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