QA Training Specialist
RoslinCT US · Hopkinton, Massachusetts, United States · $70K–$85K/yr
About the role
The QA Training Specialist supports the maintenance and management of the Training Program within the Quality Management System. They are responsible for reviewing training content, managing the Learning Management System, and ensuring compliance with health authority guidelines.
What they look for
Requirements
Candidates must have a bachelor's degree and 3-5 years of relevant Quality Assurance experience in the pharma or biotech industry. Proficiency in training administration, QMS workflows, and familiarity with 21 CFR regulations is required.
Benefits
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 QA Training Specialist is a position responsible for supporting maintenance, enhancements, and on-going management of the Training Program within the Quality Management System.
How You Will Make an Impact:
- Support the 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.
- Support review/approval of training content
- Support user administration of the Learning Management System
- Support review and approval of training plans and curricula
- 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)
- Serve as a back-up to support delivery of new hire training and periodic refresher training such as GMP training, eQMS workflows training, and data integrity training.
- Support monitor training compliance rates and reporting 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:
- Experience in Training Course and Training Plan/Curriculum review
- 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.
- 3-5 years relevant Quality Assurance experience in a pharma/biotech company working within a Quality with focus on Training/Training management or Administration
- Prior experience with supporting 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.
