Document Control Specialist

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, Quality Assurance plays a pivotal role in ensuring regulatory compliance and seamless operation of the document management system within our Electronic Quality Management System. This position is responsible for overseeing Document Control and Records Management functions, with a focus on maintaining GxP standards.

What You'll Do

• Coordinate and independently process internal documentation including SOP's, Work Instructions, Forms, Batch Records, Methods, ensuring adherence to regulatory standards.
• Become a subject matter expert (SME) on the document management system with the eQMS (Veeva Vault) so you can provide guidance to users on document authoring and revision.
• Evaluate and assess impact utilizing document change controls in the eQMS.
• Issue controlled documentation including Batch Records to manufacturing.
• Reconcile and review completed GxP documentation including process related forms and batch records.
• Scan and process executed batch records and other GxP documentation into the eQMS.
• Assist with the creation and reporting of metrics and internal KPI's related to the document management system.
• Identify and implement Document Control process improvements to ensure compliance with internal and regulatory requirements.
• Participate in the periodic maintenance and upgrades to the document management system, including validation activities and revising procedures..
• Provide support during regulatory inspections and internal audits, ensuring documentation readiness and compliance.

What You'll Bring

• High school diploma or equivalent (GED).
• Intermediate proficiency in Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• Experience in a GxP environment or other regulated industry.
• Proven track record of keen attention to detail, consistently ensuring accuracy and precision in all tasks and documentation.
• Strong communication skills, both written and verbal.

Preferred Skills:

• Associate's or Bachelors Degree.
• Experience in Quality Assurance or Document Control within a GxP environment.
• Experience with eQMS, preferably Veeva Vault or another document management system.

Work Environment and Physical Demands

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
• Flexible 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 - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches