Senior R&D QA Associate, Learning Specialist
R-242395 Senior R&D QA Associate, Learning Specialist
The Opportunity
You will be a member of the Global R&D QA department assisting the R&D QA Quality Systems organization with management of Learning Management System (LMS) activities to support the R&D Quality Management System.
The Senior R&D QA Associate will manage the content and maintenance of the LMS system on behalf R&D Quality and will coordinate learning and training management related activities for personnel supported by the R&D Quality Systems organization.
Support global R&D and QA organization in cGXP compliance related matters, including assurance that all aspects of learning management comply with GXPs, legal, regulatory requirements, and CSL Quality Manual requirements.
The Role
1) Collaborate with global R&D functions to ensure their training and LMS needs are captured, participate in LMS plans, and create consistency across the CSL R&D organization. Partner with other learning management contacts to share best practices and identify opportunities across Quality systems and Quality processes.
2) Manage R&D training requirements and training curricula:
a. Provide Subject Matter Expert (SME) advice/assessments on LMS management.
b. Responsible for LMS administration tasks including training curricula items, content, course names and assessments. Administer training within the LMS.
c. Partner with other training contacts to ensure GxP training requirements are assigned to the relevant staff within the interface functions.
d. Facilitate R&D and R&D Quality Review & Approval of training requirements assigned by interface functions.
e. Basic system troubleshooting.
3) Support internal audits and health authority regulatory inspections through providing accessible records from the LMS.
4) Provision of Quality KPIs' to show training compliance with CSL procedures. This may also include follow-up with managers and employees to ensure review of documents and update of documents. Conduct coordination of annual training curricula review.
5) Stay current with industry trends and contribute ideas to enhance the LMS experience.
6) Support the R&D QA Systems Director / Senior Manager, R&D GxP Training in daily activities as required.
7) And other job responsibilities that may be assigned from time to time.
Your Skills and Experience
- Bachelor's degree in in a relevant business, communication, technology, science discipline or equivalent education or experience.
- Requires a 3+ years' experience in use and administration of LMS.
- Pharmaceutical industry experience of at least 1-year in Quality, or R&D environment.
- Knowledge of industry regulations; with emphasis on GxP guidelines.
- General understanding of quality systems and appreciation of need for regulatory compliance.
- Influence and ensure project compliance with GxP and applicable regulations governing the application of global quality systems. Impact extends across wider company functions.
- Mentoring/teaching Team members.
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
