Document Control Specialist

Who Our Client Is :

Our client is a mission-driven healthcare organization focused on advancing innovation, improving patient outcomes, and strengthening communities. They believe that diversity fuels creativity, collaboration, and success. By fostering an inclusive workplace where every voice is valued, respected, and empowered, they create an environment where people can thrive both personally and professionally.

What Our Client Needs :

Our client is seeking a Document Control Specialist to provide administrative and technical support for document and change control activities within an electronic Quality Management System (eQMS) in a regulated environment. This role will also support quality events, CAPAs, and audit records while collaborating closely with internal teams and external partners, such as contract manufacturers. The position plays an integral role in maintaining compliance and providing back-room support during audits and inspections.

Who You Are :

You are a detail-oriented professional with experience managing documentation and quality records in a regulated industry. You excel at organization, time management, and communication, and you take pride in ensuring accuracy and compliance within a Quality Management System. You're comfortable collaborating across teams and providing dependable support in high-stakes audit environments.

What You'll Do :

• Ensure controlled documents are revised, approved, distributed, and archived in the eQMS.
• Ensure appropriate training is conducted before documents become effective.
• Maintain proper formatting of all documents in alignment with company procedures.
• Communicate with internal and external partners, including R&D, Regulatory, and Operations teams, as well as contract manufacturers.
• Support document control, change control, quality events, CAPAs, and audit modules in eQMS.
• Work with external partners to resolve technical issues related to eQMS functionality.
• Coordinate activities within the document control team to ensure requests are handled efficiently and on time.
• Provide back-room support during internal audits and regulatory inspections.

This position requires minimal travel and has no supervisory responsibilities.

What You'll Need :

What They Offer :

Our client believes that diversity fuels innovation, strengthens teams, and drives success. They are committed to fostering a workplace where every individual-regardless of background-feels valued, respected, and empowered to thrive.

Discrimination or harassment of any kind is strictly prohibited.

Our client does not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by applicable laws. Their commitment extends beyond compliance; they actively cultivate an inclusive culture where diverse perspectives are welcomed, and every employee has an equal opportunity to contribute and succeed.