Document Control Specialist

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

Responsible for leading document control and records management processes and for ensuring records are processed retained and updated appropriately. Responsible for giving direction to team members within the records management and document control groups and leading projects.

Principal Duties and Responsibilities

• Serves as the right hand of the department supervisor, helping to process changes and organize daily department priorities, by developing and maintaining trackers and meeting with individual team members
• Answers questions and gives guidance to records management and document control coordinators
• Trains peers on various processes
• Authors and develops new documents and processes
• Manages change control processes and meetings with TMs to ensure timely processing of change requests.
• Identifies and initiates projects to improve department processes with little to no oversight

Skills

• Action oriented, drives for and achieves results.
• Must be proficient in MS Office and Sharepoint.
• Strong bias for coaching and mentoring others. This includes ability to effectively train team members within a class-room or workshop setting.
• Proven strong writing and editing skills.
• Proven excellent attention to detail and proofreading skills.
• Strong organizational skills and the ability to multi-task.
• Strong and effective communicator (written and verbal).
• Motivated and proven ability to work in a team-oriented, global environment, including interacting effectively with all levels and outside contacts.
• Excellent problem identification and solving skills.
• Effective process development and process management skills.

Education

• BS/BA in engineering, business, life sciences or a similar discipline required.
• Minimum of 3 - 5 years of experience in a Quality Control, Quality Assurance or Compliance roles, 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.
• Prior experience of participating in compliance audits or inspections is preferred.