Document Control Specialist

Document Control Specialist – Therakos Healthcare Limited

Provide administrative and technical support for document control and change control activities in an electronic Quality Management System (eQMS) for a regulated industry (medical device/pharmaceutical). Support quality events, CAPAs, and audit records in eQMS. Work with internal partners across the organization and external partners such as contract manufacturers. Provide audit and inspection back‑room support.

• Skills: Excellent communication, time management, organizational and problem‑solving skills; attention to detail, multi‑tasking, experience with an eQMS for medical devices and/or pharmaceuticals.
• Experience: 2+ years in a similar role is strongly preferred. Arena eQMS experience a plus.
• Education: Bachelor’s degree in a related field; quality certifications a plus.

• Ensure controlled documents are revised, approved, distributed, and archived in eQMS.
• Ensure appropriate training is conducted before making documents effective.
• Ensure proper formatting of all documents to align with company procedures.
• Communicate with internal and external partners, such as contract manufacturers, throughout document control and change control processes. Internal partners include R&D, Regulatory, Operations, and others as needed.
• Support document control, change control, quality events, CAPAs, and audit modules in eQMS; work with external partners to resolve technical issues as needed.
• Coordinate activities within Therakos document control team to ensure requests are handled in a timely and efficient manner.
• Provide back‑room support during internal audits and regulatory inspections.

• Life/AD&D
• Short‑ and Long‑Term Disability
• 401(K) with large company match
• Health Saving Account (HSA) and Flexible Spending Account (FSA) with company match
• Wellness Program
• Employee Assistance Program (EAP)
• Generous Paid Time Off (PTO)
• Onsite with flexible core hours

The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Office‑based role in Franklin, TN with core hours flexibility.

Office‑based role expectations.

Associate

Full‑time

Quality Assurance, Training, and Administrative

Pharmaceutical Manufacturing and Medical Equipment Manufacturing