Quality Assurance Technician

Avantor•Aurora, OH

1d•Onsite

About The Position

Avantor, a Global Fortune 500 company, is looking for a dedicated Quality Assurance Technician to optimize our BPS manufacturing/QARA organization. This Aurora, OH role is full-time, working on-site Monday through Friday 3- 11:30 PM. Avantor® is a leading life sciences company and global provider of mission-critical products and services to the life sciences and advanced technology industries. A GMP manufacturing facility, the Aurora, OH location specializes in manufacturing biochemicals. Utilizing business level interpersonal, written and oral skills while adapting readily to change and managing multiple priorities; the role of the second shift QA Technician is to provide support to Avantor’s customers, quality management system programs (including cGMP and ISO), and the manufacturing operation. This position plays a vital role in facilitating Avantor’s success through quality monitoring, compliance adherence, and continuous improvement.

Requirements

High school diploma/GED
In a GMP environment
With quality assurance in a manufacturing environment
Collaboration skills (IE: Microsoft Office).
Analytical and problem solving
Record keeping

Nice To Haves

Assisting in the planning, development and implementation of quality assurance programs

Responsibilities

Inspect shipments, reconcile labels, review and release finished products.
Review QC testing documentation and results for conformance.
Confirm expiration dating and issue certificates of analysis for each lot.
Review, approve, reject quality related documents.
Respond to customer requests, including, but not limited to, investigating complaints.
Completing required paperwork for corrective and preventive actions and associated follow-up.
Maintain ISO and cGMP paperwork.
Conduct root cause analysis.
Ensure the quality requirements of all departments are being followed and are accurately documented.
Complete pm/calibration documentation files.
Manage out of service equipment.
Assure validations are performed according to approved protocols and samples provided as requested.
Prepare routine, technical, and special presentations/reports.
Prepare/ compile statistical analysis of quality assurance data.
Coordinate and perform quality assurance system internal audits.
Investigate non-conformances and determine root cause analyses.
Review current policies determining and documenting any areas that may require quality improvements.
Adhere to manufacturing procedures/ processes.
Follow standard operating procedures (SOPs).
Work in a team environment.
Work in an organized manner with attention to detail.
Perform other duties as assigned.