Helpmates

Job Title: Document Control Coordinator II

Document Control Coordinator Employee Pay: $26.00-$30.00 hourly

Document Control Coordinator Start Date: ASAP

Document Control Coordinator Schedule: 8:00am-4:30pm Monday-Friday 

We are seeking an Document Control Coordinator for a temporary opportunity with our client, a local aerospace organization! The Document Control Coordinator is responsible for collecting, maintaining, archiving, and retrieving all documents necessary to ensure compliance with procedures and FDA regulations. The Document Control Specialist monitors production operations to ensure that all users have the latest accurate revision of appropriate documentation in a timely manner.

The Document Control Coordinator job duties:

• Works in Document Control for managing documents while ensuring quality, accuracy, and integrity of the hardcopies as well as electronic files.

• Executes routine DCO change packages (e.g., process redlines, proofread, make corrections, and document training).

• Process at least 10-15 changes DCO/ECO/ECN processes per day 

• Provides guidance to other departments during the document change process.

• Maintains control of electronic and hard copy for SOPs, product drawings, labeling, artwork, process validation, manufacturing procedures, design control, marketing and educational material and test reports.

• Informs Vendors and Staff of document updates and provides controlled copies when applicable.

• Uses GDP (Good Documentation Practices) to correct records or assist others in correcting records.

• File, store, manage and track company documents for the Quality Management System.

• Performs scanning, filing, copying to maintain documents and obsolete inactive or older revision documents.

• Helps product development teams maintain drawings, work orders, DCOs, etc.

• Perform administrative tasks as required.

• Releases DCOs, updates logs and lists.

• Reviews documentation for completeness.

• Files, organizes, archives, releases documentation both as hardcopy and electronic files.

• Consult with engineering, operations, and other cross functional teams for documentation requirements.

• Verifies completeness of the DCO requirements prior to release of documents into QMS.

The Document Control Coordinator job requirements:

• BS/AS in Engineering or scientific discipline or equivalent document control experience preferred, not required

• Document Control Coordinator I: 2-4 years Quality role in Medical Device or related industry

• Extensive experience and knowledge of regulatory requirements such as GMP's, ISO, etc.

• Strong understanding of medical device manufacturing processes, receiving inspection, in-process and finished device inspections, non-conforming material resolution, CAPA, and record keeping.

• Understanding of internal and supplier auditing, process validation, metrology, and inspection equipment documentation.

• Knowledge of Product Data Management (PDM)/Product Lifecycle Management (PLM) system/software. (Agile, Omnify, Windchill, PDM, PLM, SAP

• Detail oriented required.

• Able to work in a fast-paced environment.

• Strong in Microsoft Word, Excel, Power Point, Visio.

• Documentation Maintenance of hardcopy and electronic files.

• Excellent communication skills (both written and verbal) required.

• Ability to work independently or in a team setting required.

If you believe you are a qualified candidate for our Document Control Coordinator, please click apply below to apply on our website!

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