What are the responsibilities and job description for the Document Control Specialist I, Quality Assurance position at Forge Biologics?
About Forge
Our mission at Forge Biologics, is to enable access to life changing gene therapies and help bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.
Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.
About The Team
The Quality Assurance department is dedicated to ensuring compliance with regulatory standards and maintaining the highest quality of products. Through rigorous testing, process validation, and adherence to Good Manufacturing Practices (GMP), they guarantee the safety, efficacy, and consistency of our AAV therapeutic products, supporting our commitment to delivering innovative solutions for patients in need.
About The Role
The Document Control Specialist I, Quality Assurance plays a crucial role in maintaining regulatory compliance and ensuring the efficient operation of our document management system within our Electronic Quality Management System (eQMS). This position is responsible for overseeing Document Control and Records Management functions, ensuring compliance with GxP standards and internal quality requirements.
What You’ll Do
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Life at Forge
We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge’s core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.
HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge’s vision, mission and goals.
We’ve Got You Covered
We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.
Our mission at Forge Biologics, is to enable access to life changing gene therapies and help bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.
Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.
About The Team
The Quality Assurance department is dedicated to ensuring compliance with regulatory standards and maintaining the highest quality of products. Through rigorous testing, process validation, and adherence to Good Manufacturing Practices (GMP), they guarantee the safety, efficacy, and consistency of our AAV therapeutic products, supporting our commitment to delivering innovative solutions for patients in need.
About The Role
The Document Control Specialist I, Quality Assurance plays a crucial role in maintaining regulatory compliance and ensuring the efficient operation of our document management system within our Electronic Quality Management System (eQMS). This position is responsible for overseeing Document Control and Records Management functions, ensuring compliance with GxP standards and internal quality requirements.
What You’ll Do
- Coordinate and process internal documentation, including Standard Operating Procedures (SOPs), Work Instructions, Forms, Batch Records, and Methods, ensuring adherence to regulatory standards.
- Serve as subject matter expert for the document management system (eQMS - Veeva Vault), providing guidance on document authoring and revision.
- Monitor and coordinate document change controls, change requests, controlled copies, and periodic reviews within the eQMS, ensuring timely stakeholder evaluation.
- Issue controlled documentation and labeling, including Batch Records, to manufacturing, ensuring accuracy and compliance.
- Scan and process executed batch records and other GxP documentation into the eQMS efficiently.
- Track and report key metrics and internal KPIs related to document management performance.
- Identify and support process improvements to enhance document control workflows and maintain compliance with internal and regulatory standards.
- Collaborate with cross-functional teams to streamline document control processes and enhance operational efficiency.
- Support regulatory inspections and internal audits, ensuring documentation readiness and compliance.
- High school diploma or equivalent (GED); Associate’s or Bachelor’s degree in a scientific, technical, or business-related field preferred.
- 1 years of experience in document control, quality assurance, compliance monitoring; or similar role.
- Familiarity with regulatory requirements related to documentation control (e.g., FDA, EMA, ISO, cGMP).
- Ability to analyze and improve document control processes, ensuring compliance and efficiency.
- Proficiency in Microsoft Office Suite (Outlook, Excel, Word, Powerpoint) and ability to quickly learn new software applications.
- Strong attention to detail, ensuring accuracy and precision in documentation.
- Effective communication skills, both written and verbal, with the ability to collaborate across teams and departments.
- Experience in Quality Assurance or Document Control within a GxP environment.
- Experience with eQMS, preferably Veeva Vault or another document management system.
This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Life at Forge
We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge’s core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.
HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge’s vision, mission and goals.
We’ve Got You Covered
We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.
- Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
- Competitive PTO (plus 14 paid company holidays)
- Annual bonus for all full-time employees
- 401(K) company match
- Fully-stocked kitchen with free food/drinks
- 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
- Employee Assistance Program
- Wellness benefits (financial planning services, mental health counseling, employer paid disability)
- Professional & Personal development resources
- Onsite gym
