Document Control Lead | Process & Compliance

Aequor; Warsaw (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

Aequor in the United States (Indiana) seeks a records management professional to lead document control and ensure compliant records processing, retention, and updates. You will guide team members and drive department priorities.

Responsibilities include developing trackers, training peers, authoring new documents, and managing change control projects with minimal oversight in a regulated life sciences environment.

Qualifications

• BS/BA in engineering, business, life sciences or similar.
• 3–5 years in Quality Control, Quality Assurance or Compliance, preferably in a document control or function in the medical device or life sciences industry.
• Working Knowledge of 21CFR Parts 11 and 820, including ISO 13485 QMS.
• Experience with electronic Document Management (eDM) systems is preferred.
• Participation in compliance audits or inspections is preferred.

Responsibilities

• Lead document control and records management processes.
• Guide and direct team members within the records management and document control groups.
• Develop trackers and coordinate daily department priorities.
• Identify and initiate projects to improve department processes with little oversight.
• Train peers and author new documents and processes.
• Manage change control processes and meetings to ensure timely processing of change requests.

Skills

Action oriented

MS Office

SharePoint

Mentoring

Training

Writing skills

Editing skills

Attention to detail

Organizational skills

Communication

Team collaboration

Problem solving

Process development

Education

BS/BA in engineering, business, life sciences

3–5 years QA/compliance experience

21CFR Parts 11 and 820; ISO 13485 QMS knowledge

Experience with electronic Document Management (eDM) systems

Tools

eDM systems

Job description

Aequor in the United States (Indiana) seeks a records management professional to lead document control and ensure compliant records processing, retention, and updates. You will guide team members and drive department priorities.

Responsibilities include developing trackers, training peers, authoring new documents, and managing change control projects with minimal oversight in a regulated life sciences environment.