Clinical documentation specialist [h1.location_city]

Sr. Documentation Specialist

The St. Louis office is currently seeking a Sr. Documentation Specialist focusing on multiple regulatory projects for the St. Louis site, representing a global leader in medical device manufacturing, known locally for its exceptional work culture and innovative solutions.

Why This Opportunity?

Join a team that is shaping the future of healthcare technology. You’ll work in a collaborative, innovative environment where your documentation experience ensures the highest quality and compliance standards for life-saving products.

Job Description

As a Sr. Documentation Specialist, you will play a crucial role in ensuring compliance with company procedures and FDA Quality Systems Regulations by

managing document control and interfacing with multiple departments. You will be responsible for generating and updating essential documents such as Bill of

Materials, recipes, and engineering change masters are managed in our ERP system. Your role will also involve proofreading, composing, and modifying documentation to= ensure accuracy and adherence to standards.

Responsibilities

• Use change management systems and other defined processes to ensure compliance with company procedures and FDA Quality Systems Regulations.
• Generate or update Bill of Materials, recipes, and documents in Engineering Change Masters within the ERP system.
• Interface with multiple department personnel, including other sites, to ensure alignment and release of instrument change processes, BOMs, and recipes.
• Communicate with internal and external review teams to obtain necessary approvals for document release.
• Facilitate projects by assisting with organizational tasks for various engineering teams.
• Proofread documentation for accuracy and adherence to standards, consolidating and reconciling comments from production or engineering personnel.
• Compose, modify, and format assembly documentation, including instrument assembly, test procedures, and packaging drawings, according to departmental standards.

Essential Skills

Work Environment

Additional Skills & Qualifications

Work Environment

Enjoy benefits such as two weeks of PTO and ten paid holidays. This role requires collaboration with international teams and adherence to departmental styles and standards. The work environment encourages attention to detail and strong organizational skills.

Job Type & Location

This is a Contract position based out of St. Louis, MO.

Pay and Benefits

The pay range for this position is $35.00 - $45.00 / hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following :

Workplace Type

This is a fully onsite position in St. Louis,MO.

Application Deadline

This position is anticipated to close on Feb 20, 2026.