Coord 1, Quality Document Sys Mgmt - Onsite (Urgent Need)

Millenniumsoft•Branchburg, NJ

3d•Onsite

About The Position

The Quality Document Management Systems Coordinator 1 will be responsible for a variety of tasks related to records management, document control, audit support, and facilities/site services within the Quality Department of a Medical Devices Company. This role requires strong organizational skills, attention to detail, and familiarity with regulated industry documentation practices.

Requirements

High school diploma or GED required.
1–5 years of administrative experience in a regulated industry environment (pharmaceutical, medical device, clinical laboratory, or combination product preferred).
Familiarity with GMP, GLP, or ISO 13485 documentation practices is an asset.
Prior experience with document management systems or electronic quality management systems (eQMS) is a plus.
Strong organizational skills with demonstrated ability to manage multiple concurrent tasks and priorities with accuracy.
High attention to detail and commitment to data integrity in all record-keeping activities.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
Comfort with electronic document management platforms.
Effective written and verbal communication skills.
Ability to work both independently and collaboratively within a Quality team environment.
Discrete handling of confidential quality and client records.
Professional demeanor and customer-service orientation.

Nice To Haves

Associate's degree or higher in Business Administration, Life Sciences, Healthcare Administration, or a related field preferred.

Responsibilities

Perform QA review for GMP documentation, verifying ALCOA requirements and test results against specifications.
Issue controlled forms daily in accordance with document control procedures.
Check out and check in project folders for disposition review, maintaining logs and verifying completeness.
Coordinate offsite archival activities for paper records, including scheduling pickups/drop-offs and facilitating retrieval.
Perform daily scanning of quality documents and upload to designated electronic locations.
Process Electronic Change Record Orders (ECROs) in accordance with site procedures.
Schedule internal and client audits, facility meetings, client meetings, and site visits.
Prepare audit rooms by printing and placing necessary documents, setting out supplies, and ensuring readiness.
Provide audit runner and/or back-room support during audits, including document retrieval and logistical coordination.
Coordinate and place catering/lunch orders for audits and meetings.
Process site-specific purchase orders and one-time purchase requests for Quality Department supplies.
Manage lab coat inventory rotation, arranging dry cleaning services and maintaining a tracking log.