Document Control Specialist

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.

Position overview: This position supports creation and/or updates to controlled Quality system procedures and process changes. Collaborates with internal Subject Matter Experts (SMEs) to process document updates in the electronic change control system. Maintains the document control and training modules within the QCBD system.Assists with maintaining company’s training program.

Must be able to plan, organize, prioritize and implement multiple concurrent tasks and performs under minimal supervision.

Maintains organized and audit ready controlled document storage room.

Responsibilities:

Document Control

Create and coordinate all controlled document files, both electronic and hard copy

Manage change order requests as assigned

Identify improvements to the Document Control System

Works with a variety of SMEs from various departments to quickly update documents while ensuring compliance with documentation control procedures (e.g. Disposition, tasks assign, etc.)

2.Controlled Document Maintenance

Maintain revision control of all controlled documents via document control system, hard copy and/or logs as appropriate

Ensure proper formatting, numbering, revision control and archiving of documents.

Assist with processing Document Change Order Requests

Review Change Orders for completeness and accuracy before routing for approval

Edit documents in Change Orders to ensure correct formatting

Work with change order initiators to ensure their change orders comply with document control procedures.

Maintain master, obsolete and archive files (electronic and paper).

Maintain and organize the document control room to ensure audit readiness.

Distribute Change Orders to required approvers.

Track Change Orders and follow procedures to facilitate review, approval and release

Implement document changes upon approval and notify personnel for training requirements, per procedure.

File hard copy records such as CAPA, NCR, DHR etc.

Ensure logs are maintained and up to date

Assign document numbers as needed

3.Training Program and Records

Assist with updates to Training System as requested

Assist with monitoring the status of the training process

Periodically follow up with trainees to complete any outstanding training in a timely manner by sending out training reminders.

Provide reports on the status of training.

Ensure initial and ongoing training occurs as needed for new or revised processes and procedures.

Scan and file training records in accordance with established policies and procedures

Record training completions in QCBD when hard copy training records are provided (i.e. group training)

Maintain employee training records (electronic and paper)

Assist with generating onboarding documents for new hires.

Ensure logs are maintained and up to date

4.External Standards

Purchase external standards as requested.

Monitor standard updates/action items and notify SME to complete standard evaluations

Ensure log is maintained and up to date.

5.Others

May undertake additional activities and/or projects to address Quality

Required Experience:

Associate’s degree or equivalent from two-year college or technical school; three years related experience and/or training; or equivalent combination of education and experience.

Experience with QMS Electronic Documentation systems preferred.

Knowledge, Skills and Abilities:

Ability to produce clear, precise, understandable documentation while meeting tight deadlines.

Strong computer skills, including Microsoft Office applications (i.e., Word, Excel, PowerPoint)

Proficient with advanced Microsoft Word skills (i.e., formatting, templates, tables, bookmarks, flowcharts, etc.) required

Must have excellent documentation skills

Strong organization skills

Attention to detail and accuracy a must

Ability to successfully manage a number of tasks and projects simultaneously

Experience with and understanding of ISO 13485 and FDA Quality System (21 CFR 820) is preferred

Team player, good written/oral communicator

Able to thrive in a small, entrepreneurial environment

Must be organized and able to coordinate activities with internal departments and outside vendors

Excellent interpersonal, written and verbal communication skills