Quality Document System Management - Coordinator 1

• Perform QA review for GMP documentation.
• Verifies ALCOA requirements are met and test results against specifications.
• Issue controlled forms on a daily basis in accordance with document control procedures.
• Check out project folders for disposition review; maintain a controlled check-out log with dates, reviewer names, and return status.
• Check in project folders following disposition; update the controlled check-in log and verify folder completeness prior to filing.
• Check in and check out in-process folders on a daily basis; maintain an accurate and up-to-date tracking log for all active in-process records.
• Coordinate offsite archival activities for paper records (PV books, logbooks, notebooks) as applicable:
• Schedule pickups and drop-offs with designated archival vendor (TBD).
• Maintain a log of records sent offsite and facilitate retrieval of archived records upon request.
• Perform daily scanning of quality documents and upload to designated electronic drives or document management locations in a timely manner.
• Process Electronic Change Record Orders (ECROs) in accordance with site procedures.

• Schedule internal and client audits, facility meetings, client meetings, and site visits as requested.=
• Prepare the audit room the day prior to each audit:
• Print and place agenda, attendance sheet, and lunch list on the conference table.
• Set out water bottles, lab coats, safety glasses, branded pens and notebooks, monitor, hotspot, keyboard, and mouse.
• Fill the coffee machine with water and perform a general readiness walkthrough to ensure all materials are in place.
• Provide audit runner and/or back-room support during audits as applicable (e.g., document retrieval, logistical coordination, escorting visitors).
• Coordinate and place catering/lunch orders for audits and meetings as required.

• Process site-specific purchase orders and one-time purchase requests for Quality Department supplies in accordance with procurement procedures.
• Manage lab coat inventory rotation: arrange delivery to and pickup from dry cleaning services on an established frequency; maintain a tracking log.

• Associate's degree or higher in Business Administration, Life Sciences, Healthcare Administration, or a related field preferred.
• High school diploma or GED required; relevant experience may be considered in lieu of degree.

• 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 when interfacing with internal stakeholders and external clients/auditors.

Pavan.p@sunrisesys.com