Document Control/Training Specialist (Temporary)

Tenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s most advanced candidates include TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM), TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC), and TN-301, a small molecule HDAC6 inhibitor being initially developed for heart failure with preserved ejection fraction (HFpEF). Tenaya also has multiple early-stage programs progressing through preclinical development.

Tenaya is headquartered in South San Francisco, California, USA, with a team that comprises over 70 employees. Inspired by the majesty of Tenaya Peak in Yosemite National Park, our name represents the tenacity of our team in reaching our ultimate peak – the delivery of new therapies for heart disease to the patients who need them.

For more information, please visit www.TenayaTherapeutics.com and follow us on LinkedIn.

Diversity & Inclusion is a core Value for Tenaya Therapeutics, and we encourage those from under-represented communities to apply.

The Document Control/Training Specialist (contract, part-time) will manage document workflows through respective document life cycle, utilizing Veeva Vault – Document Management System (DMS), maintain employee training records utilizing Veeva Vault Training - Learning Management System (LMS), coordinate document offsite storage, and provide GxP training to employees as needed.

This is a part-time, temporary assignment expected to last 3 months.

Responsibilities

• Maintain document control function utilizing Veeva Vault – DMS and facilitate the process of initiating document workflow, creating, reviewing, approving, and archiving company standard operating procedures, product specifications, analytical methods, forms, protocols and reports, master batch records, etc.
• Ensure current versions of controlled GxP documents are readily available and maintain the Veeva Vault- DMS in compliance with all applicable regulations.
• Maintain employee training records utilizing Veeva Vault – LMS, coordinate, and provide GMP training to Tenaya’s GMP employees as needed.

Requirements

• Bachelor’s degree in scientific discipline or health-related field.
• Minimum 5 - 8 years of experience in Document Control and/or Training Management in the biotechnology or pharmaceutical industry.
• Experience using Veeva Vault and Vault Training– Document Management System and Learning Management System is highly preferred, experience using comparable electronic document management system is also considered.
• Knowledge of FDA regulations, 21 CFR Part 11, 210, 211, 600, ICH Quality Guidelines.
• Strong organizational skills and attention to detail.
• Strong ability to prioritize, multi-task, and work in an evolving environment.
• Self-motivated, able to function independently with minimal supervision in a fast-paced start-up team environment.
• Ability to manage ambiguity and cope with uncertainty in fast-paced environment.
• Demonstrate good judgement by thinking critically and tackling ambiguity and complex problems effectively and efficiently in phase appropriate manner.
• Intermediate skills using Microsoft Office applications.
• Good presentation and written/verbal communication skills.
• Proficient in MS Word, particularly formatting Word documents as required.
• Proficient in Adobe particularly editing pdf files as needed.
• Position level and compensation are subject to years of applicable industrial experiences