Document Control Specialist

SPECTRAFORCE; Warsaw (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

Spectraforce is seeking a Document Control Specialist to lead document control and records management in Warsaw, Indiana. This onsite role focuses on directing team efforts, maintaining trackers, and guiding coordinators to ensure compliant and timely processing of changes.

The position requires 3–5 years in QC/QA/compliance with 21 CFR Part 11/820 and ISO 13485, plus experience with eDM systems and MS Office/SharePoint. Labor and life-sciences experience are valued.

Qualifications

• BS/BA in engineering, business, life sciences or a similar discipline.
• Minimum 3–5 years in Quality Control/QA/Compliance roles, preferably with document control in the medical device or life sciences industry.
• Working knowledge of 21CFR Parts 11 and 820, ISO 13485 QMS.
• Experience with electronic Document Management (eDM) systems preferred.
• Prior experience participating in compliance audits or inspections preferred.
• Proficient in MS Office and SharePoint.

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

Coaching & mentoring

Written and verbal communication

Attention to detail

Organizational skills

Teamwork in global environment

Training delivery

Education

BS/BA in engineering, business, life sciences or similar

Tools

eDM systems

Document management systems

Job description

Position Title: Document Control Specialist

Work Location: Warsaw, Indiana

Assignment Duration: 12 months

Work Arrangement: Onsite

Position Summary: 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.

Key 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

Qualification & Experience

• 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.
• 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.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.