Quality Assurance Specialist (Contract Position)

As a Quality Assurance Specialist you will support the implementation and maintenance of the organizations Quality Management System (QMS) to ensure products and processes meet established quality regulatory and performance roleis responsible forsupporting Quality Assurance activities across document control training compliance equipment calibration tracking batch record review andlotrelease activities within a regulated laboratory and manufacturing environment.

Key Responsibilities

1. Document Review and Control:

• Review controlled quality documents for formatting completeness accuracy and compliance with company procedures prior toapprovalrouting.

• Assistwith 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 retrievablein accordance withdocument control procedures.

• Review customer facing materials labeling and product documentation to ensure approved content and proper document control prior to release.

1. Training and Support:

• Assign required training within the electronic Quality Management System (eQMS) based on document revisions new procedures onboarding activities and trainingplans.

• Monitor training completion status and follow up with employees and managersregardingoverdue or incomplete training assignments.

• Maintainaccurateand current training recordsin accordance withcompany procedures and Quality Management System requirements.

• Escalate overdue training missing records or training compliance issues to QA management asappropriate.

1. 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 andmaintainedin theappropriate 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.

• Assistwith equipment labeling and status tracking to ensure calibrated equipment is properlyidentified.

1. Batch Record Review / Lot Release:

• Perform review of batch records test records and supporting documentation for completeness legibility and adherence to approved procedures.

• Verify thatrequiredsignatures 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.

• Identifydocumentation errors discrepancies or missing information and communicate findings to theappropriate departmentfor correction.

• Perform product disposition andlotrelease activitiesin accordance withapproved procedures and quality requirements.

• Maintain organized and traceable batchrecordand release documentationin accordance withrecord retention requirements.

Educationand Experience:

• Bachelors 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 medicaldevice 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.