Document Control Specialist

BioAge is a platform-driven, clinical-stage biotechnology company that is mapping human aging to develop a pipeline of therapies that treat disease and extend healthy lifespan. Our proprietary human-first platform encompasses >65M molecular measurements spanning 45+ years of human aging, and unlocks a universe of novel biological insights and druggable mechanisms for age-related disease. We currently have three clinical programs in our growing portfolio–two first in class and two first in indication–for immune aging and muscle aging. Ultimately, our mission is to develop therapies that change the nature of aging and provide patients with years more healthy time. To date, BioAge has raised $127M from Andreessen Horowitz, Kaiser Foundation Hospitals, and others. 

For additional information about BioAge, visit the company’s website at www.bioagelabs.com.
Job Responsibilities

• Help to create, implement, and maintain a Document Control System (manual and/or electronic) to manage internal as well as external controlled documents/records
• Develop, implement, and maintain workflows for creating, approving, storing, updating controlled documents
• Develop, implement, and maintain Document Change Control (DCC) and CAPA systems
• Document Control activities, including, but not limited to formatting, coordinating the review and approval process, tracking, and routing of controlled documents
• Format and edit SOPs
• Initiate and revise applicable Document Control SOPs, Policies and Work Instructions, etc., as required
• Evaluate training requirements, maintain training matrix, configure curricula and training requirements, manage training records
• Provide user assistance and training on document control and record management systems, processes, and procedures
• Provide support for audits and regulatory agency inspections
• Represent Document Control in project and functional meetings

Job Qualifications

• Bachelor or advanced degree
• Previous Document Control experience (4 years or more desired)
• Working knowledge of Quality Systems, electronic documentation systems, data retrieval, and electronic file formats
• Working knowledge of GXP regulations, quality systems (Document Control, Training, Change Control, Computer System Validation, 21CFRPart11) and guidance documents
• Experience working with TMF and TMF reference model desired
• Proficient with computers and word processing software such as MS Office 365
• Excellent attention to detail, project and time management skills as well as the ability to manage multiple priorities in a fast-paced environment
• Excellent verbal and written communication and interpersonal skills and ability to work effectively in a team environment
• Ability to analyze and reconcile moderately complex issues 
• Demonstrate leadership skills through example

BioAge offers a comprehensive compensation package, as well as generous paid time off in addition to company-observed holidays. We provide comprehensive health and wellness benefits (medical, dental, and vision insurance), childcare and fertility benefits, along with a 401(k) retirement savings plan which includes matching employer contributions. We also pride ourselves in giving employees many opportunities for career development including a generous annual budget for continued learning, a direct and open-door environment, and a dedication to training and skill development.

At BioAge, everyone matters and we embrace diversity and differences while we learn from each other. We are an equal opportunity employer. BioAge prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. BioAge conforms to the spirit as well as to the letter of all applicable laws and regulations.