What are the responsibilities and job description for the Senior Document Control Specialist position at VitriVax?
The Senior Document Control Specialist position in Quality Assurance is responsible for document control activities under the VitriVax Quality Management System. This includes the development, implementation, and maintenance of Document Control systems and activities across all departments. The Senior Document Control Specialist will also be assigned Quality Assurance responsibilities as directed by department management. This role reports to VP, Regulatory and Quality Assurance and will work with a team of Scientists in the Research and Development spaces as well as personnel within the GxP space. This is a full-time position, located in Boulder, Colorado. Responsibilities and Duties : Oversee the organization and maintenance of the document control system, ensuring accurate tracking of all controlled documents (e.g., SOPs, batch records, validation protocols, etc.) and select Research and Development (R&D) documents (reports, methods, etc.). Manages the electronic document management system (eDMS). Manage hard-copy controlled documents and applicable Research and Development documents including developing an organized and secured filing system. Develops procedures, processes, and training around document control and the use of the eDMS. Plans and executes multiple tasks to ensure controlled documents are managed per procedures and applicable regulations. Provides training to VitriVax personnel on the eDMS. Acts as liaison with the eDMS vendor for training, support, and new modules. Identify areas for improvement within the document control process and propose solutions to optimize document management workflows. Act as the primary point of contact for document control-related inquiries and issues. Develops and tracks goals and facilitates continuous improvements around document control. Provides Quality Assurance support as requested to include activities such as document review, approvals, and auditing. Education and Experience : Education : Bachelors / Associates degree, or equivalent work experience. Minimum of 5 years of experience in document control or a related field, with at least 3 years in a GxP-regulated pharmaceutical or biotechnology environment. Proven experience managing document control systems, preferably in a GxP environment. Strong understanding of GxP regulations, specifically FDA, and other relevant regulatory standards. Proficiency with eDMS (TMS preferred) and Microsoft Office Suite. Attention to detail, organizational skills, and the ability to manage multiple tasks and deadlines. Excellent written and verbal communication skills, with the ability to collaborate across departments. Strong problem-solving skills and a proactive approach to improving processes. Core Skills and Competencies : All VitriVax employees are expected to share the following values. Integrity We are team players who say what we do and do what we say. We respect our obligations and are transparent in our communication. We present all data factually. When presented with ambiguous situations, we strive to do the right thing Innovation We create value by developing superior products and processes. We have a curious mindset, apply an analytical approach and take calculated risks. We take on difficult problems and break barriers. PassionWe are passionate about making vaccines accessible to everyone. We share our enthusiasm with purpose. We are never satisfied with the status quo and want to make a difference. Quality We seek quality information, decisions and people. We put safety first and approach every opportunity with a right first-time mindset that is focused on the end goal. We are committed to continuous improvement and elimination of waste. Salary and Benefits : Salary for the position will be determined by the applicants experience and alignment with current and future responsibilities. Annual Salary Range : $80,000 - $110,000 DOE All full-time employees are eligible for the following benefits. Stock Options 401(k) with generous Company match Flexible work schedule Generous PTO Health, Dental and Vision insurance Short-Term and Long-Term Disability insurance Voluntary AD&D Insurance Flexible Spending Account Optional Pet Insurance and Discount Plans VitriVax, Inc., is an Equal Opportunity Employer and does not discriminate based on race, color, gender, sexual orientation, gender identity or expression, religion, disability, national origin, protected veteran status, age, or any other status protected by applicable national, federal, state, or local law.
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Salary : $80,000 - $110,000
