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Sr. QA Training Specialist

RoslinCT US · Hopkinton, Massachusetts, United States · $80K–$100K/yr

2 d ago
Senior (5-10 yrs) Full-time United States
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About the role

The Sr. Training Specialist is responsible for the oversight, enhancement, and management of the Training Program within the Quality Management System. This includes creating training curricula, delivering new hire and refresher training, and monitoring compliance metrics.

What they look for

Training plan development Curriculum development Quality management system Learning management system GMP training Data integrity training Problem-solving Oral communication Written communication Microsoft office suite Quality assurance Regulatory compliance Continuous improvement Cross-functional collaboration 21 CFR part 210/211 21 CFR part 11

Requirements

Candidates must have a bachelor's degree and 5-8 years of relevant Quality Assurance experience in the pharma or biotech industry. Proficiency in training management, regulatory guidelines such as 21 CFR Part 210/211, and strong communication skills are required.

Benefits

Flexible work environment Attractive benefits package

Full description

WHO WE ARE

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.

THE ROSLINCT WAY

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.

ACCELERATING YOUR FUTURE

The Sr. Training Specialist is position responsible for supporting the oversight, enhancements, and on-going management of the Training Program within the Quality Management System.

How You Will Make an Impact:

  • Support the oversight, implementation and maintenance of Learning Management System in in line with applicable health authority guidelines, regulations, key performance indicators and compliance trends, and operational needs.
  • Creates and maintains 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 periodic basis.
  • Complete other responsibilities, as assigned within the Quality Assurance department.
  • Serve as a user administrator for the Quality Management System

What You Will Bring:

  • 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

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.