Responsible for developing and delivering training those who perform testing activities within the Virology Operations department according to current Good Laboratory Practices (cGLPs). This is individual will ensure employees are current to industry standards in knowledge and expertise, compliantly trained in job related activities performed by all employees and improving the standard of execution performed through the operation.
• Follows, executes and trains other to follow and execute Standard Operating Procedures (SOPs) and Batch Records (BRs), in addition to identifying and address regulatory gaps and issues
• Understands the concept of and has performed or experience with testing processes and methods
• Develops and delivers hands on training to those who perform testing activities,
• Participates, supports, presents and represents as an SME during regulatory inspections and client audits
• Participates, reviews, approves, provides information in the development of and trains others to author basic technical documents such as non-conforming events and deviations
• Trains, coaches and mentor’s others operational testing techniques such as gowning, media preparation, thaw, passage and harvesting overall systems and operations, and maintain record files and databases
• Oversees performance and is able to explain the ‘why’ of acceptable and unacceptable aseptic technique practices and can identify technique gaps and opportunities
• Identifies gaps and/or issues, suggests, participates, implements and leads continuous improvement ideas and recommends path forward for decision making
• Follows compliance and regulatory requirements and current Good Laboratory Practices (cGLPs) and understands ‘why’ behind the regulations.
Creates, revises, reviews and finalizes material documents, as well as the ability to train, mentor and manage trainees on performance of material related activity
• Trains others on the performance of solution and material preparation
• Performs material procurement activities, such as scheduling, forecasting, receiving and organizing, in addition to being able to identify, communicate and resolve material discrepancies
• Assigns training work assignments, as well as teaches, coaches and mentors others to solve basic technical problem
• Communicates, is accountable for, makes adjustments and delegates training schedule, assignments, tasks and needs
• Performs well under direct supervision and works independently on training tasks and processes
• May be required to work Holidays and weekends
• May be required to work Overtime
• May be required to work outside of normal business hours
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Other duties as assigned
• May be required to assist in other departments
Experience / Education:
• Associates’/Bachelor’s (science preferred) degree with over 5 years of relevant or equivalent experience
• Possess learning and/or training accreditations and certifications, including curriculum design (preferred)
• Prior experience in the pharmaceutical and biotechnology industry, ideally in cell and gene therapy
Knowledge / Skills / Abilities:
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
• Has basic and fundamental engineering and mechanical knowledge, technical transfer activities and validation activities.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English
• Proficient in Microsoft (Excel, Word, Outlook)
Equal Opportunity Employer Minorities/Women/Veterans/Disabled