Facilities Compliance Specialist II
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.
Job Summary
The Facilities Compliance Specialist II will create, manage, and maintain technical documentation for the Facilities Department, including Quality Systems documents such as Deviations, Change Controls, CAPAs, SIAs, and Risk Assessments. This role will be responsible for working with other departments to ensure delivery of project milestones mitigating impact to site operations. It is critical to have experience in technical writing, compliance, and data analysis in a regulated environment. This employee will communicate, consult and advise department personnel and management on document status and escalate issues that may affect ultimate results or close-out.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Generate and facilitate the completion of quality system documents for the Facilities Department (Deviations, CAPAs, Change Controls, etc)
• Ensure all documentation is clear, concise, and adheres to company standards and regulatory guidelines
• Complete routine and some non-routine documentation assignments within prescribed timeline under general supervision
• Work closely with Facilities and other departments to gather information and ensure accuracy and completeness of documentation
• Facilitate document reviews and approvals incorporating feedback from cross-functional departments
• Collaborate in writing and editing technical documents including standard operating procedures (SOPs), batch records, technical reports, etc
• Communicate results and escalate concerns verbally and in writing
• Develop and maintain relationships with internal stakeholders and associated departments
• Provides solutions of moderate to complex scope to continuously improve documentation processes and templates to enhance clarity, efficiency, and compliance
• Perform all other related duties as assigned.
Job Qualifications
• Bachelor’s degree in Life Sciences, Biotechnology, Biochemistry, or related field preferred
• Minimum of 1-3 years of technical writing experience in the biotechnology or pharmaceutical industry, preferably in cell and gene therapy
• Knowledge of cGMP compliance and systems required
• Knowledge of facility and equipment maintenance requirements preferred
• Exceptional writing, editing, and proofreading 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 and project management skills
• Excellent communication and interpersonal skills
The pay range for this position is $77,700 - $86,900. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
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.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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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Biochemistry, Biology, Biotech, Facilities, Pharmaceutical, Science, Operations