Training Specialist

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.

We are seeking a Training Specialist for our Biologics Testing Solutions site located in Malvern, PA.

Under minimal supervision, responsible for providing, coordinating, documenting, maintaining, and scheduling basic through advanced training activities including but not limited to new hire orientation, departmental and interdepartmental specific trainings, regulatory site initiatives and cGMP responsibilities. Also responsible for developing, revising, and implementing the use of training tools, including documents and processes to support the overall training program. Assist in managing and reviewing learning management systems for personnel’s training record maintenance.

ESSENTIAL DUTIES AND RESPONSIBLITIES:

• Assist in developing training programs; including materials, coordinating and delivering trainings for new and existing employees in areas such as:
  • basic through advanced level skills
  • use and interpretation of standard operating procedures (SOPs)
  • cGMP topics
  • specific departmental procedures
  • use and interpretation of protocols
  • safety and technical
  • administrative and other site processes and procedures.
• Assist in collaborating with Training Department management, cross-site personnel and internal/external resources to develop and implement new training procedures
• Work with department management to coordinate and/or provide training for department personnel.
• Assist with the development, revision and review of internal training processes

MINIMUM QUALIFICATIONS:

• Bachelor’s degree (B.A./B.S.) or equivalent in scientific discipline.
• 3-5 years related experience in a cGMP laboratory facility (pharmaceutical or biotech) and training environment.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Proficient with MS Office applications and the ability to learn and use various software packages.
• Advanced understanding of regulations and cGMP/SOPs.
• Must have strong written and verbal communication skills.
• Ability to quickly adapt to changing environments, prioritize and meet deadlines.
• Must be able to effectively perform public speaking and utilize effective training principles.
• Knowledge of computer network navigation and common software applications.

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.