Quality & Site Administrative Coordinator

Meridian Bioscience, Inc.•Billerica, MA

7d•$29 - $37

About The Position

The Quality & Site Administrative Coordinator provides administrative, coordination, and Quality Systems support to the Magellan Diagnostics / Billerica site. The role supports day-to-day Quality and regulatory activities, including document control, record organization, data entry, recall and field-action administration, audit and inspection readiness, and coordination of Quality-related information and requests. It also provides general site administrative and coordination support and serves as a liaison with Meridian corporate functions and other sites. The position requires strong organization, attention to detail, follow-through, and the ability to manage multiple priorities in a regulated environment. The coordinator supports the site’s Quality Management System and related Quality processes; maintains controlled Quality and regulatory records; and assists with trackers, logs, electronic systems, CAPAs, deviations, complaints, audits, and training activities. The role provides administrative support for recalls, field actions, and regulatory correspondence, and assists with response tracking, address research, reconciliation, and supporting records. The position supports FDA, ISO, and other audits and inspections by retrieving and organizing documents, tracking requests, coordinating responses, and helping maintain inspection-ready records. It also coordinates meetings, calendars, agendas, visitors, and routine site administrative needs; works with corporate functions and shared services; and provides administrative and document-control support for applicable Environmental, Health and Safety activities. The coordinator may identify workflow improvements, help implement new administrative or Quality-system processes, and support special projects and other assigned duties.

Requirements

High school diploma or equivalent required.
Strong organizational and time-management skills.
Exceptional attention to detail and accuracy.
Strong written and verbal communication skills.
Ability to manage multiple priorities and follow through on time-sensitive requests.
Proficiency with Microsoft Office, particularly Excel, Word, and Outlook.
Ability to maintain accurate records, trackers, and databases.
Ability to handle confidential and sensitive information appropriately.
Ability to work effectively across departments and with both site and corporate personnel.
Ability to support audits and inspections in a fast-paced, highly regulated environment.
Strong problem-solving and follow-up skills.
Ability to work independently while recognizing when escalation or additional support is needed.

Nice To Haves

Associate degree, technical certification, or relevant college coursework.
Two to four years of administrative, coordination, document-control, Quality Systems, or related experience.
Experience working in a medical device, diagnostics, pharmaceutical, laboratory, manufacturing, or other regulated environment.
Experience with electronic document-management or QMS systems, including QT9, MasterControl, or similar systems.
Experience with FDA, ISO 13485, or other regulated-site audit/inspection support.
Experience with document control or QMS administration.
Experience supporting recalls, field actions, complaints, or other regulatory activities.
Experience with EHS documentation or administrative support.
Experience working with eQMS, ERP, or other controlled business systems.

Responsibilities

Provide administrative support for the site’s Quality Management System and related Quality processes.
Maintain, organize, route, and retrieve controlled Quality and regulatory records in accordance with applicable procedures.
Assist with document-control activities, including record organization, tracking, routing, filing, and retrieval.
Maintain Quality and regulatory trackers, logs, and other records requiring accurate and timely data entry.
Support organization and maintenance of records in applicable electronic systems, including eQMS and document-management systems.
Assist Quality personnel with routine administrative follow-up and coordination associated with CAPAs, deviations, complaints, audits, training, and other Quality activities.
Provide administrative support for product recalls, field actions, and related regulatory activities.
Receive, log, track, and organize certified mail and other regulatory correspondence.
Assist with response tracking, address research, reconciliation, and maintenance of supporting records.
Maintain accurate logs and status information for regulatory and field-action activities.
Coordinate document collection and administrative follow-up across internal stakeholders as directed by Quality or Regulatory leadership.
Support FDA, ISO, and other internal or external audits and inspections through document retrieval, organization, request tracking, and administrative coordination.
Assist with maintaining audit and inspection request logs and coordinating responses with subject-matter experts.
Support audit and inspection back-room activities, including locating and organizing requested records, coordinating document routing, and tracking outstanding requests.
Help maintain site records and documentation in an organized, readily retrievable, and inspection-ready condition.
Provide day-to-day administrative and coordination support for site leadership, Quality, Operations, and other site functions as appropriate.
Coordinate meetings, calendars, agendas, invitations, and related logistics for site and cross-functional activities.
Coordinate with Meridian administrative personnel and corporate functions at other locations to support site communication, meeting participation, scheduling, and resolution of routine administrative needs.
Assist with routine coordination with corporate functions, including IT, Facilities, HR, and other shared services.
Help track and coordinate routine site administrative needs and follow-up items.
Support visitors, meetings, and other site activities as needed.
Provide administrative and document-control support for applicable Environmental, Health and Safety activities.
Assist with organization, routing, and maintenance of EHS-related records and documentation.
Coordinate with Quality, EHS, Facilities, and other functions on documentation and site-support activities.
Identify opportunities to improve administrative workflows, record organization, tracking, and coordination.
Assist with implementation of new administrative or Quality-system processes.
Support special projects and other duties as assigned.