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.Basic Summary
We are seeking a Technical Coordinator for our Biologics Testing Solutions site located in Wayne, PA
You may be required to work a rotating shift schedule that may require weekend hours.
Perform deviation and nonconformance investigations, author and revise batch records and protocols, and communicate support activities to supervisor and manager across departments. Assist with management of client requests for scheduling and technical information; assist with client audits. Assure that client CAPAs are addressed in a timely manner. ESSENTIAL DUTIES AND RESPONSIBLITIES:
- Write and revise SOPs, Batch Records, and other technical documents.
- Lead (act as project manager for) teams investigating major and critical nonconformance and deviations, including gathering information through structured root cause analysis.
- Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
- Own and manage change controls associated with Molecular Biology laboratories and equipment.
- Train technicians on basic laboratory procedures, gowning, and applicable cGMP procedures.
- Assist with management of client requests for technical information; assist with client audits.
- Bachelor's degree (B.S.) or equivalent in biology or related discipline.
- Two to four years industry related experience in a biological laboratory.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Able to communicate effectively in a group setting.
- Basic Microsoft Office skills preferred.
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.