About the Role
Works under limited supervision and supports the department by providing the development, coordination, and assurance of GLP compliant training procedures and practices. Works, as delegated by department management, to ensure the successful completion of training activities and maintenance of technical skills. Provides administrative and organizational support in training planning, scheduling, coordination, document management and reporting. Performs quality control (QC) and/or maintenance of plans, SOPs, worksheets, raw data, study binders, and data archiving. May provide support for other work groups as needed.
What You’ll Do Here
• Develop and implement Standard Operating Procedures and qualification requirements, ensuring compliance with FDA (GLP), L&I, and other regulatory agencies
• Research new procedures, train and oversee their implementation
• Coordinate with department trainers and management to schedule training and cross training
• Train and cross train in the technical execution of current protocols and standard operating procedures (SOPs), daily activities associated with all functions of the department and other related services
• Help identify training staff and ensures uniform training content across all trainer staff
• Responsible for the development and maintenance of training programs and may assist with the creation and maintenance of training forms or electronic records
• Focus on process management and standardization to improve efficiency and quality
• Determine proper documentation of training procedures and data acquisition in an effort to accurately document compliance with plans, SOPs and Protocols while facilitating the needs of department management
• Work with all groups to improve processes
• Monitor and communicate training deadlines to ensure adherence to set schedules
• Communicate training deadlines to study personnel and department management
• Track milestones and ensure training schedules are up to date
• Manage the timely review and assembly of training documentation
• Assign and oversee duties to personnel necessary to complete training objectives
• Provide hands-on training of staff for classes and technical skills, and assesses competency
• Respond to Quality Assurance audits for training processes and corrective actions that require training
• Perform QC review of data in a timely manner
• Work with different departments to help ensure consistency of training practices and organization
• Support and participate in study procedures if necessitated by workload
• Supervise studies, procedures and research assignments and coordinate duties of personnel and study teams
• Participate in evaluation, performance or maintenance of new systems or equipment
• Maintain general organization and cleanliness of work area, including cleaning and disinfecting procedure rooms and preparation areas
What You’ll Need to Succeed
• BA/BS in biological sciences or related science degree; education may be substituted with related laboratory experience and administrative skills
• 2+ years working in a vivarium setting required
• 1+ years staff training experience required
• 3+ years working in a research or regulated environment preferred
• Professional certification in area of expertise preferred
• Intermediate computer skills including proficiency with Microsoft Office suite
• English proficiency both written and verbal; general reading, writing and verbal communication skills
• Intermediate maths skills
• Ability to work cross functionally on process improvements
• Practical problem solving skills and can deal with a variety of concrete variables
• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Demonstrate attention to detail
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Skills Required
- BA or BS in biological sciences or a related science field, or equivalent related laboratory experience and administrative skills
- At least 2 years of experience working in a vivarium setting
- At least 1 year of staff training experience
- At least 3 years of experience working in a research or regulated environment
- Professional certification in the area of expertise
- Intermediate computer skills, including proficiency with Microsoft Office Suite
- Written and verbal English proficiency
- Intermediate mathematics skills
- Ability to work cross-functionally on process improvements
- Practical problem-solving skills and ability to handle varied concrete variables
- Ability to interpret written, oral, diagrammatic, and scheduled instructions
- Attention to detail
What We Do
Outsourcing made easy with a one-stop solution to early-phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!







