Maintenance Quality Systems Specialist

Overview

Department:
Maintenance

Location:

Brighton, Michigan

Job Title:

Maintenance Quality Systems Specialist

Reports to:

Maintenance and Calibration Manager

Biovire Inc., a pharmaceutical manufacturing company, is searching for a Maintenance Systems Specialist for the Brighton, Michigan manufacturing site to work closely with the Maintenance department and supporting staff. The Maintenance Systems Specialist is responsible for the administration, documentation, and quality compliance of the site Maintenance Management System. This role ensures that all maintenance records, preventative maintenance documentation, and change activities are accurate, complete, traceable, and audit-ready in accordance with GMP and site quality standards.

• Ensure all maintenance and calibration documentation complies with GDP (Good Documentation Practices).
• Review maintenance and calibrations records for completeness, accuracy, and proper approvals prior to record closure.
• Perform routine documentation audits within the maintenance and calibration systems to identify gaps or deviations.
• Initiate, author, manage, and close maintenance and calibration related deviations, including documenting event descriptions, performing root cause analysis, coordinating required actions, and ensuring timely approval and closure in the quality system.
• Own the full lifecycle of Corrective and Preventative Actions (CAPAs) associated with maintenance and calibration documentation, systems, and processes, including initiation, action definition, implementation tracking, and formal closure.
• Initiate, author, assess, implement, and close Change Controls (CCs) impacting maintenance and calibration systems and documentation.
• Coordinate cross-functional input from Maintenance, Calibration, Quality Assurance, Engineering, and Validation, to ensure documentation is complete, accurate, and aligned with approved quality processes.
• Conduct effectiveness checks for maintenance and calibration related CAPAs by reviewing system data, documentation trends, and audit outcomes.
• Ensure all deviations, CAPA, and Change Control documentation complies with GMP, GDP, and ALCOA+ data integrity principles, including proper attribution, contemporaneous entry, and approval.

This is a key role within the Biovire organization; therefore, the expectations and credentials of the candidate are demanding. The educational and work history requirements represent the minimum for this position:

• Education/Experience Requirements:
• 3+ years of experience in a highly regulated manufacturing environment with direct responsibility for quality documentation
• High School Diploma or equivalent required.
• Demonstrated technical knowledge of maintenance and calibration principles, terminology, and workflows, sufficient to accurately review, author, and assess maintenance documentation within a regulated environment.
• Hands-on experience working within maintenance and calibration management systems, with responsibility for documentation accuracy, traceability, and record lifecycle management.
• Experience performing and documenting root cause investigations related to documentation or system deficiencies.
• Working knowledge of data integrity principles (ALCOA+) and their application to Maintenance, Calibration and Quality records.
• Effective cross-functional communications skills when coordinating documentation activities with Maintenance, QA, Calibration, and Engineering.
• Experience initiating, authoring, managing, and closing deviations, Change Controls, and CAPAs, in a highly regulated environment, including documentation of event descriptions, root cause analysis, corrective actions, approvals, and formal closure.
• Proven experience supporting internal audits, client audits, and regulatory inspections, including direct interaction with auditors and inspectors.

• Experience in pharmaceutical manufacturing, contract manufacturing organizations (CMOs), or biologics facilities.
• Hands-on maintenance or technical operations experience, including exposure to preventative maintenance, corrective maintenance, or equipment troubleshooting.