Training Specialist

The Training Specialist will join the Civica, Inc. ( Civica ) organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance.

The Petersburg site serves as Civica’s new fill finish facility dedicated to the manufacture and supply of essential generic and biosimilar insulin sterile injectable medications.

Responsibilities of the position include establishing and maintaining quality and compliance processes associated with training and development to ensure requirements for Good Manufacturing Practices (GMPs), are being met from the onset of building and qualifying the facility leading to successful U.

S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

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).
• Act as a subject matter expert for the Veeva 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.
8 days ago