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.Job Summary Reporting to the Manager, Compliance, the Compliance Specialist I is responsible for creating, managing, and maintaining technical documentation for our cell and gene therapy manufacturing site. This includes writing, editing, and reviewing documents such as quality systems (deviations, change controls and capas). The ideal candidate will be a critical thinker with excellent writing skills.ESSENTIAL DUTIES AND RESPONSIBILITIES:
Generate and support the management of quality system documents for the manufacturing site (Deviations, CAPAs, Change Controls, etc)
Ensure all documentation is clear, concise, and adheres to company standards and regulatory guidelines
Complete routine documentation assignments within prescribed timeline under close supervision
Gather information and ensure accuracy and completeness of documentation
Facilitate document reviews and approvals, incorporating feedback from cross-functional teams and clients
Collaborate in writing and editing technical documents including standard operating procedures (SOPs), batch records, technical reports, etc
Communicate results and/or concerns verbally and in writing
Recognize and determine solutions to continuously improve documentation processes and templates to enhance clarity, efficiency, and compliance
Aid in performing trainings for functional departments
Stay up to date on industry standards and regulations
Perform other duties as assigned
Job Qualifications
Bachelor's degree in Life Sciences, Biotechnology, Biochemistry, or related field preferred
Minimum of zero (0) to 1 years of technical writing experience in the biotechnology or pharmaceutical industry, preferably in cell and gene therapy
Exceptional writing, editing, and prooing skills with attention to detail
Ability to interpret and present complex scientific data in a clear and concise manner
Proficient in Microsoft Office Suite and document management systems
Strong organizational skills
Excellent communication and interpersonal skills
Compensation DataThe pay range for this position is $68,000 - $76,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.About Cognate BioServicesCognate BioServices, Inc., a Charles River Company, is the premier commercial-ready CDMO for cell and gene therapy needs. We are a dynamic, results-driven organization focused on providing the broadest range of expertise across the various cell types and technologies used in the commercialization of cell & gene therapies for regenerative medicine, cellular immunotherapy, and advanced cell therapy companies, organizations, and institutions.We offer a unique combination of standard and custom services to companies across all points of clinical and commercial development. Our development and manufacturing services are focused on clients seeking rapid development of products from clinical studies into commercial manufacturing, with a unique capacity to handle all aspects of scale-up and commercial readiness.Cognate leverages the combined know-how and expertise of its business, scientific, and technical teams to successfully develop and manufacture autologous and allogenic products across multiple cell-based technology platforms from start to finish, for you and your patients.For more information, visit www.cognatebioservices.comEqual Employment OpportunityCharles 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 crrecruitmentUS@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.224327
