Document Control Specialist

Akkodis; Warsaw (IN); On-site; USD 30,000 - 36,000; Full time

Job summary

Akkodis, Inc. is seeking a Document Control Specialist for an onsite role with a global industry leader near Warsaw IN.

The Document Control Specialist is responsible for leading document control and records management processes and for ensuring records are processed, retained, and updated appropriately. Qualifications include 2+ years of experience in a Quality Control, Quality Assurance or Compliance roles, preferably in a document control function in the medical device or life sciences

Qualifications

• 2+ years in Document Control, Quality Control, QA or Compliance.
• Experience in medical device or life sciences is a plus.
• Familiarity with 21 CFR Part 11/820 and ISO 13485 QMS is beneficial.
• Experience with electronic Document Management (eDM) systems preferred.
• Ability to participate in compliance audits or inspections.
• Strong writing, editing and proofreading skills.
• Excellent organizational and multi-tasking abilities.
• Effective written and verbal communication

Responsibilities

• Lead document control and records management processes.
• Process changes and maintain trackers; coordinate with team members.
• Answer questions and guide records management and document control coordinators
• Train peers on various processes
• Authors and develops new documents and processes
• Manage change control processes and meetings for timely approvals
• Identify projects to improve department processes with minimal oversight

Skills

Document Control

Quality Assurance

Compliance

MS Office

Writing

Tools

eDM systems

Job description

Akkodis, Inc. is seeking a Document Control Specialist for an onsite role with a global industry leader near Warsaw IN. The Document Control Specialist is responsible for leading document control and records management processes and for ensuring records are processed, retained, and updated appropriately. Qualifications include 2+ years of experience in a Quality Control, Quality Assurance or Compliance roles, preferably in a document control function in the medical device or life sciences industry.

Salary Range: $24 per hour; salary negotiable based on experience, education, geographic location, and other factors

This is a great opportunity to get your foot in the door with a leading global employer!

Document Control Job Responsibilities Include:

• 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

Qualifications:

• Minimum of 2 years of experience in a Document Control, Quality Control, Quality Assurance or Compliance roles, preferably in the medical device or life sciences industry.
• Working Knowledge of 21CFR Parts 11 and 820, including ISO 13485 QMS is a plus.
• Experience with electronic Document Management (eDM) systems is preferred.
• Prior experience of participating in compliance audits or inspections is preferred.
• Action oriented, drives for and achieves results.
• Must be proficient in MS Office.
• Strong bias for coaching and mentoring others. This includes ability to effectively train team members within a classroom 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).

If you have questions about the position, please contact Kathy Becher at [e-mail].

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

The Company will consider qualified applicants with arrest and conviction records.