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Contract-QA Training Associate
2 months ago
The Contract-QA Training Associate executes the Regulated Training program. This position collaborates with Subject Matter Experts, across business and regulated functional areas, to ensure training needs are facilitated and implemented. The Contract-QA Training Associate assists operational staff, within the department, to execute consistent, reliable, harmonized application of policies, practices, and customer support. This position will report to the Sr. Director, Global Quality Systems & Process Improvement.
This role is required to be onsite 5 days a week in our Emeryville, CA Office.
In the role you will:
• Primary administration of regulated training program within the electronic quality management system eQMS - ZenQMS.
• Maintain training curricula per Agenus SOPs to ensure required training is appropriately assigned for all employees who have a responsibility or accountability within a regulated process.
• Work with various departments to create and update training curricula and assignments, as needed.
• Work with hiring managers to create and assign training curriculum for new hires on a weekly basis.
• Schedule and host QA orientation, for all new hires, on a weekly basis and assign training in eQMS system.
• Track training compliance and provide reports, as needed. Maintain company-wide training compliance by completing various workflows/ tasks in the eQMS system.
• Troubleshoot issues and implement effective solutions and corrective actions.
• Provide timely QA training communications via email and Monday.com including weekly eQMS Fast Facts.
• Provide training support on various projects, as requested.
Qualifications: About You
• Related experience in Training Assignments or Document Control, Quality Systems, and/or Compliance-related positions, preferably in cGMP and GCP or comparable regulated environments.
• Proficient experience with eDMS and/or LMS software required.
• Proficient experience with software applications such as MS Word, Excel, PowerPoint, Box, and Dropbox.
• Bachelor's degree required
• Strong communication skills
• Technical proficiency administrating EDMS and LMS software.
• Demonstrated ability to effectively communicate information and ideas and to interact effectively with direct reports, peers, senior management, regulatory officials, auditors, contractors, and consultants.
• Ability to apply regulated requirements and current industry practices in the administration of the regulated training, document control, & records management programs.
• Must be able to perform functions under minimum supervision. Receives general instructions on new work; refers to policies and practices for guidance.
• Ability to prioritize appropriately to support company goals.
