Quality Systems Training Specialist

Danaher•Austin, TX

6d•Remote

About The Position

The Quality Systems Training Specialist is responsible for developing and maintaining a compliant GMP training program by partnering with cross-functional teams to ensure training strategies, qualification requirements, and learning activities meet global regulatory and quality standards. This position reports to the Head, Document Control and Training and is part of the Quality Assurance Team and will be fully remote. In this role, you will have the opportunity to: Collaborate with cross-functional teams (internal and external) to establish and maintain training strategies that align with applicable regulatory requirements. Ensure compliance with training requirements defined in 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q8, ICH Q9, ICH Q10, ISO 9001, ISO 13485 and other international guidelines as appropriate. Independently administer and maintain the electronic Learning Management System (LMS), including training assignments, curricula, job codes, user access, qualification programs, periodic reviews, and training record management. Conduct impact assessments for new and revised procedures to determine appropriate training requirements, delivery methods, and qualification activities, including Read & Understand, exams, instructor-led training, and competency assessments. Monitor training compliance, identify overdue or at-risk training activities, investigate training-related issues, and work directly with functional leadership to drive timely resolution. Provide guidance to managers and associates regarding training requirements, qualification expectations, and compliance obligations.

Requirements

3+ years of relevant experience in creating/facilitating training programs; biotech, pharma, or medical device document control experience preferred.
Experience with establishing and maintaining training programs in electronic document management systems, MasterControl experience preferred.
Bachelor’s Degree required; life science related field, preferred.
Strong foundational knowledge in competency based/application based training.

Responsibilities

Collaborate with cross-functional teams (internal and external) to establish and maintain training strategies that align with applicable regulatory requirements.
Ensure compliance with training requirements defined in 21 CFR Part 210, 211, 610, EU Annex 13, EudraLex Vol 4, ICH Q7, ICH Q8, ICH Q9, ICH Q10, ISO 9001, ISO 13485 and other international guidelines as appropriate.
Independently administer and maintain the electronic Learning Management System (LMS), including training assignments, curricula, job codes, user access, qualification programs, periodic reviews, and training record management.
Conduct impact assessments for new and revised procedures to determine appropriate training requirements, delivery methods, and qualification activities, including Read & Understand, exams, instructor-led training, and competency assessments.
Monitor training compliance, identify overdue or at-risk training activities, investigate training-related issues, and work directly with functional leadership to drive timely resolution.
Provide guidance to managers and associates regarding training requirements, qualification expectations, and compliance obligations.