Essential Duties and Responsibilities

• Design, develop and coordinate training program needs.
• Develop and / or review and maintain site curriculums and training requirements in the Veeva Electronic Learning Management System (EDMS).
• Collaborate across functional areas to develop and align the site training requirements.
• Ensure that all training requirements and curriculum is reviewed within required intervals.
• Ensure GMP training documentation is maintained and controlled per company procedures.
• Author procedural documents related to area of responsibility.
• Participate in activities to support regulatory agency inspections.
• Create dashboards and training reports within Veeva.
• Monitor, track, and trend training.
• Act as document control to route procedural documents in the Veeva EDMS to ensure accuracy, completeness, and alignment with procedures.
• Review new and revised procedures, ensuring document changes are implemented into Petersburg procedures.
• Support document control and other quality systems activities as needed.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• A minimum of four years experience in the pharmaceutical or medical device industries.
• Bachelor or associate level degree in Pharmaceutical Sciences, Biology or related field preferred. High School degree with 6 years of experience of cGMP production experience may be considered.
• Strong project management, organization, and execution skills with ability to managing multiple projects and priorities.
• Excellent interpersonal and written communication skills and experience using various software / electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices; can learn by doing.
• Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills and share knowledge with others.

Preferred Qualifications :

• Experience with Veeva.
• Yellow belt certification.

Last updated : 2024-05-16