Document Control Specialist

Therakos Healthcare Limited; Franklin (TN); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Life/AD&D

Short- and Long-Term Disability

401(K) with large company match

Health Saving Account (HSA)

Flexible Spending Account (FSA)

Wellness Program

Employee Assistance Program (EAP)

Generous Paid Time Off (PTO)

Job summary

A healthcare company is seeking a Document Control Specialist in Franklin, TN, to provide support for document and change control activities in an electronic Quality Management System. The ideal candidate will have a Bachelor’s degree, 2+ years of relevant experience, and excellent communication skills. This full-time position offers flexible office hours and comprehensive benefits, including a robust 401(K) plan and generous paid time off.

Qualifications

• 2+ years in a similar role strongly preferred.
• Experience with eQMS for medical devices/pharmaceuticals.

Responsibilities

• Ensure controlled documents are revised, approved, distributed, and archived in eQMS.
• Conduct appropriate training before documents are effective.
• Ensure proper formatting of all documents.
• Communicate with internal and external partners.
• Support document control and quality events in eQMS.
• Coordinate requests within the document control team.
• Provide back-room support during audits and inspections.

Skills

Excellent communication

Time management

Organizational skills

Problem-solving skills

Attention to detail

Multi-tasking

Experience with eQMS for medical devices/pharma

Education

Bachelor’s degree in a related field

Quality certifications

Tools

Arena eQMS

Job description

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.

Job Requirements

• 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.

Responsibilities

• 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.

Benefits

• 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

Disclaimer

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.

Working Conditions

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

Physical Requirements

Office‑based role expectations.

Seniority Level

Associate

Employment Type

Full‑time

Job Function

Quality Assurance, Training, and Administrative

Industries

Pharmaceutical Manufacturing and Medical Equipment Manufacturing