Document Control/Training Specialist

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 3-6 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 4 - 7 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

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.