Document Control Specialist

LanceSoft, Inc.; Warsaw (IN); On-site; USD 65,000 - 95,000; Full time

Job summary

LanceSoft, Inc. is seeking a Records Management and Document Control lead to guide a team and optimize processes in a regulated environment.

Responsibilities include drafting procedures, training staff, and coordinating change control while ensuring compliance with 21CFR Part 11/820 and ISO 13485 requirements.

Qualifications

• BS/BA in engineering, business, life sciences or a similar discipline required.
• 3-5 years of experience in Quality Control, Quality Assurance or Compliance roles, preferably in a document control or life sciences context.
• Working knowledge of 21CFR Parts 11 and 820, including ISO 13485 QMS.
• Experience with electronic Document Management (eDM) systems preferred.
• Prior experience participating in compliance audits or inspections preferred.
• Must be 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.
• Answers questions and provides 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 to ensure timely processing of change requests.
• Identifies and initiates projects to improve department processes with little oversight.

Skills

MS Office proficiency

SharePoint

Training & mentoring

Excellent writing/editing

Attention to detail

Organizational skills

Written & verbal communication

Team collaboration (global)

Problem solving

Process development

Education

BS/BA in engineering or related field

3–5 years in Quality Control/QA/Compliance

Knowledge of 21CFR Part 11 & 820; ISO 13485

Experience with electronic Document Management (eDM)

Audit/inspection experience

Tools

MS Office Tools

SharePoint

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.