QA Training Specialist: GMP Training & Compliance Lead

RoslinCT; Hopkinton (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization. The QA Training Specialist role supports maintenance and ongoing management of the Training Program within the Quality Management System, on-site in Hopkinton, MA.

You will implement and maintain the Learning Management System, review training content, administer users, and collaborate with cross-functional teams to ensure training compliance and continuous improvement.

Qualifications

• Bachelor’s degree in related discipline.
• 3-5 years QA experience in pharma/biotech focusing on Training/Training management or Administration.
• Experience supporting training plans and curricula.
• Experience serving as Quality reviewer/approver.
• 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.

Responsibilities

• Support LMS implementation and maintenance in line with health authority guidelines.
• Review/approve training content.
• Administer Learning Management System (user management).
• Review and approve training plans and curricula.
• Collaborate with cross-functional teams to ensure training compliance.
• Assess and determine fit-for-purpose training tools and methodologies.
• Back-up delivery of new hire training and refresher trainings (GMP, eQMS workflows, data integrity).
• Monitor training compliance rates and reporting metrics to leadership.
• Support Quality Culture enhancement efforts.
• Assist health authority inspections and client audits.
• Update procedures, processes, provide training, and report QMS metrics.

Skills

Training review

Problem solving

Communication

Organized work

Accuracy mindset

Microsoft Office

Education

Bachelor’s degree

Tools

Microsoft Office

Job description

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization. The QA Training Specialist role supports maintenance and ongoing management of the Training Program within the Quality Management System, on-site in Hopkinton, MA.

You will implement and maintain the Learning Management System, review training content, administer users, and collaborate with cross-functional teams to ensure training compliance and continuous improvement.