Sr. QA Training Specialist

About Us

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

Responsibilities

• Support the oversight, implementation and maintenance of Learning Management System in line with applicable health authority guidelines, regulations, key performance indicators and compliance trends, and operational needs.
• Create and maintain training plans, curricula, and learning courses.
• Collaborate with cross-functional teams to ensure training compliance based on approved training curricula and periodically review training curricula with functional teams.
• Assess and determine “fit for purpose” training tools and methodologies based on training needs, including (but not limited to) computer-based training, On-the-Job Training (OJT), and Instructor Led Training (ILT).
• Support review/approval of training content.
• Responsible for content creation and delivery of new hire training and periodic refresher trainings such as GMP training, eQMS workflows training, and data integrity training.
• Provide training on Quality Systems workflows and processes on a routine basis and support additional refresher training.
• Monitor training compliance rate and report compliance metrics to the leadership team, including overdue training assignments for individual functional teams as and when requested.
• Support Quality Culture enhancement efforts.
• Support health authority inspections and client audits, including corrective actions.
• Support QMS team efforts to update procedures, processes, provide training, and reporting QMS metrics on a periodic basis.
• Complete other responsibilities, as assigned within the Quality Assurance department.
• Serve as a user administrator for the Quality Management System.

Requirements

• Expertise in Training Plan and Curriculum development, oversight, and maintenance.
• Effective problem-solving capabilities.
• Strong oral and written communication skills.
• A highly organized work style that ensures timely execution of tasks.
• A mindset that ensures accurate results.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Qualifications

• Bachelor’s degree in related discipline.
• 5-8 years relevant Quality Assurance experience in a pharma/biotech company working within a Quality with focus on Training/Training management.
• Prior experience with implementing and/or oversight of training plans and curricula.
• Prior experience serving as Quality reviewer/approver.
• Prior experience driving continuous improvement initiatives.
• Ability to partner cross-functionally and integrate feedback with quality systems.
• Ability to work independently to meet objectives and timelines.
• Experience in 21 CFR Part 210/211 and 21 CFR Part 11; familiar with ICH regulations/guidelines.

This is an on-site position.