Document Control Coord

Medline • Glens Falls, NY

3d

About The Position

Responsible for maintaining and overseeing the revision control of corporate documents. This role will also be responsible for coordinating the daily/weekly/monthly workflow and reviewing documentation for the department.

Requirements

• High School Diploma or equivalent
• At least 1 years of experience in Quality or Regulatory Affairs.
• Intermediate skill level with SAP.
• Intermediate skill level in Microsoft Excel and Microsoft Office.
• Working knowledge of regulations regarding document control and GDP.

Responsibilities

• Ensure that corporate documents are properly maintained, updated, and filed correctly (DMR, ECNS, reports, artwork/print plates as applicable).
• Initiate and circulate document changes for review and update.
• Assist in ensuring that all three-year reviews are completed for all procedures.
• Generate COC/COA/COT certificates when requested.
• Maintain and update monthly training reports and update training groups as needed.
• Coordinate and ensure training is completed on new/revised documents.
• Log training in Reliance for non-email training groups.
• Distribute monthly report pertaining to deviation activity and CAPA activity.
• Act as a Reliance Administrator for site as applicable.
• Assist with customer labeling creation and oversee artwork review and release process as it pertains to print plate and custom insert labeling as applicable.
• Assist with additional projects and department duties assigned as necessary.
• Perform 3-year document/procedure reviews for Namic Glens Falls
• Own training groups and training assignment for Namic Glens Falls employees
• Send notifications and follow up on overdue training assignments, overdue 3-year reviews, and other document-related activities.
• Support DHR collection, retrieval, filing, scanning, archiving.
• Attach deviations to DHRs when applicable.
• Serve as document reviewer prior to approval process
• Process documents through ETQ/Reliance (procedure updates, Qual records, etc.)
• Review and process routine environmental reports
• Serve as backup for sterilization load release in SAP
• Coordinate document collection and organization for reviews requested by Namic Glens Falls Sister sites (i.e. P090, HNL)
• Serve as a primary coordinator and reviewer in the backroom during internal and external audits, ensuring that all documentation is organized and accurate, reviewed prior to sharing with the front room.
• Maintain and update Quality Metrics trackers, including but not limited to AAs, QDAs, and other metrics reviewed during the monthly Quality Meeting (as needed).
• Serve as backup testing coordinator for environmental monitoring (as needed).

Benefits

• health insurance
• life and disability
• 401(k) contributions
• paid time off
• Employee Assistance Program
• Employee Resource Groups
• Employee Service Corp

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED