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

Key Responsibilities

• Records Management & Document Control:
  • 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.
  • Cook 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.
• Audit & Meeting Support:
  • 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).
  • Cook coordinate and place catering/lunch orders for audits and meetings as required.
• Facilities & Site Services:
  • 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.

Qualifications

• Education: 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.
• Experience: 1-5 years of administrative experience in a regulated industry environment (pharmaceutical, medical device, clinical laboratory, or combination product preferred).
• Familiarity: Familiarity with GMP, GLP, or ISO 13485 documentation practices is an asset.
• Prior experience: Prior experience with document management systems or electronic quality management systems (eQMS) is a plus.

Skills & Competencies

• Organizational skills: Strong organizational skills with demonstrated ability to manage multiple concurrent tasks and priorities with accuracy.
• Attention to detail: High attention to detail and commitment to data integrity in all record-keeping activities.
• Microsoft Office Suite: Proficiency in Microsoft Office Suite (Word, Excel, Outlook); comfort with electronic document management platforms.
• Communication: Effective written and verbal communication skills.
• Teamwork: Ability to work both independently and collaboratively within a Quality team environment.
• Confidentiality: Discrete handling of confidential quality and client records.
• Professionalism: Professional demeanor and customer-service orientation when interfacing with internal stakeholders and external clients/auditors.