Salary :
As a Quality Assurance Specialist, you will support the implementation and maintenance of the organization’s Quality Management System (QMS) to ensure products and processes meet established quality, regulatory, and performance requirements. This role is responsible for supporting Quality Assurance activities across document control, training compliance, equipment calibration tracking, batch record review, and lot release activities within a regulated laboratory and manufacturing environment.
Key Responsibilities
Document Review and Control:
Review controlled quality documents for formatting, completeness, accuracy, and compliance with company procedures prior to approval routing.
Assist with processing document changes, document routing, version updates, obsolescence, and archival activities within the electronic Quality Management System (eQMS).
Maintain controlled records and ensure documents are properly filed, organized, and retrievable in accordance with document control procedures.
Review customer facing materials, labeling, and product documentation to ensure approved content and proper document control prior to release.
Training and Support:
Assign required training within the electronic Quality Management System (eQMS) based on document revisions, new procedures, onboarding activities, and training plans.
Monitor training completion status and follow up with employees and managers regarding overdue or incomplete training assignments.
Maintain accurate and current training records in accordance with company procedures and Quality Management System requirements.
Escalate overdue training, missing records, or training compliance issues to QA management, as appropriate.
Equipment Calibration and Maintenance:
Maintain calibration and preventive maintenance schedules for laboratory and manufacturing equipment.
Coordinate calibration and maintenance activities with internal personnel and external service providers.
Track completion of calibration and maintenance activities and ensure records are uploaded and maintained in the appropriate systems.
Review calibration certificates and maintenance records for completeness and accuracy prior to filing.
Notify management of overdue calibrations, maintenance activities, or equipment status concerns.
Assist with equipment labeling and status tracking to ensure calibrated equipment is properly identified.
Batch Record Review / Lot Release:
Perform review of batch records, test records, and supporting documentation for completeness, legibility, and adherence to approved procedures.
Verify that required signatures, dates, calculations, and supporting documentation are present and complete prior to QA approval or escalation.
Assist with review of production and laboratory records to support lot release activities.
Identify documentation errors, discrepancies, or missing information and communicate findings to the appropriate department for correction.
Perform product disposition and lot release activities in accordance with approved procedures and quality requirements.
Maintain organized and traceable batch record and release documentation in accordance with record retention requirements.
Education and Experience:
Bachelor’s degree in Biological Sciences, Biomedical Engineering, Chemistry, Microbiology, or related scientific field, or equivalent combination of education and industry experience.
Minimum of 3 years of experience working within a regulated laboratory, manufacturing, or quality environment.
Experience working within regulated industries, preferably medical device, in vitro diagnostics, biotechnology, pharmaceutical, or related industries, with exposure to Quality Management Systems (QMS).
Experience with electronic Quality Management Systems (eQMS) or electronic document management systems (eDMS) required.
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