Senior Specialist, Quality Training
New
4
4DMTBiotechnology
Remote, United StatesContractSenior
Salary55 - 64 USD per hour
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Job Details
- Experience
- 3-5 years of progressive experience in biotech/pharmaceutical industry; 2+ years supporting GxP training programs, LMS management, or Quality Systems
- Required Skills
- Project ManagementMicrosoft Office
Requirements
- B.S. or B.A. preferred.
- 3-5 years of progressive experience in biotech/pharmaceutical industry.
- 2+ years supporting GxP training programs, LMS management, or Quality Systems.
- General knowledge of adult learning principles, instructional design, and project management.
- General understanding of global GxP regulations (FDA, EMA, ICH, etc).
- Experience working within one or more GxP disciplines (GMP, GCP, GLP, or GDP).
- Knowledge of LMS administration and processing.
- Proficiency in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint), Adobe Acrobat, and survey tools.
- Knowledge of good documentation principles.
- Excellent written and verbal communication skills.
- Strong organizational skills.
Responsibilities
- Support the training governance framework, policies, and standards for the GxP training program.
- Serve as the LMS business administrator to create, edit, and retire training items, curricula, and training assignments in GxP functional areas.
- Coordinate and aid with regularly scheduled GxP / Quality onboarding training for new hires.
- Partner and support functional leaders across the business with enterprise-wide, role-based training requirements and implement within the LMS.
- Manage, track, and prioritize training requests from the business for curricula and course management, training assignments, and reporting.
- Gather and provide training data to integrate training metrics for department communications or Quality Management Review process.
- Support the records management of training and qualification records (physical and electronic).
- Support audits/inspections of the training program and provide assistance during regulatory inspections.
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