Job Description

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:

1. 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

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