Quality & Site Administrative Coordinator

This 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. The position also provides general site administrative and coordination support and serves as a liaison with Meridian corporate functions and other sites. The role requires strong organization, attention to detail, follow-through and the ability to manage multiple priorities in a regulated environment.

About Meridian Bioscience

• Meridian Meridian Bioscience is a fully integrated life science company that develops manufactures, markets and distributes a broad range of innovative diagnostic products.
• We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis.
• We are looking for talented and passionate individuals that help drive our vision.
• Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems

Responsibilities

• The Quality & Site Administrative Coordinator provides administrative, coordination, and Quality Systems support to the Magellan Diagnostics / Billerica site.
• Quality Systems & Document Control 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/document-management systems.
• Assist Quality personnel with routine administrative follow-up and coordination associated with CAPAs, deviations, complaints, audits, training, and other Quality activities.
• Recall & Regulatory Support 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.
• Audit & Inspection Readiness Support FDA, ISO and other internal or external audits and inspections through document retrieval, organization, request tracking, and administrative coordination.
• Assist with maintaining audit/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.
• Site Administration & Coordination 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.
• EHS / Cross-Functional Support 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.
• Improvement & Other Support 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.

Requirements

• High school diploma or equivalent required.
• Two to four years of administrative, coordination, document-control, Quality Systems, or related experience preferred.
• Experience working in a medical device, diagnostics, pharmaceutical, laboratory, manufacturing, or other regulated environment strongly preferred.
• 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.
• Experience with electronic document-management or QMS systems preferred, including QT9, MasterControl, or similar systems.
• 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.

Preferred

• Associate degree, technical certification or relevant college coursework preferred.
• Additional Experience 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.

Pay

Up to 10% Compensation Range: $29.00–$37.00/hour