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Avantor, a Global Fortune 500 company, is looking for a dedicated Quality Assurance Associate to optimize our Performance Materials organization. This role is full-time, on-site in Paris KY where you will work 3 days on/ 2 off 6PM- 6AM within a 24/7: 365 operation.
Job Responsibility:
Observing cGMP good documentation practices
Maintaining work activities to meet operational requirements
Monitoring staff performance in accordance to established standards
Mentoring less-experienced peers and assist supervisors
Issuance of controlled manufacturing and testing documents to Manufacturing and Quality Control as per the production schedule
Monitoring the equipment program including calibration and preventative maintenance timelines and complete quality assurance sign-off for equipment workorders
Issuance and reconciliation of equipment and room logbooks
Conducting reconciliation, filing and archiving all quality-controlled records
Storing completed documents in the appropriate data files and coordinating off-site document storage with third party as necessary
Providing pre-run line clearance to manufacturing
Consulting with document originators to resolve discrepancies
Working closely with internal departments to ensure commitment to customer is met in a timely manner
Providing batch record review support
Writing and revising SOPs as part of process improvement initiatives or as needed to support the department
Coordination of document control activities and delegating with other quality coordinators to drive workload completion at the direction of quality management
Participating and driving the quality and safety culture of the site
Performs other duties as assigned
Requirements:
Highschool/ GED
Quality assurance experience (2+ years)
Quality (cGMP
ISO standard preferred)
Collaboration skills (MS Office)
Experience with Quality Assurance/Quality control/Operations in a regulated environment
Reading, analyzing, and interpreting general business periodicals, professional journals, technical procedures, or governmental regulations
Writing reports and procedures
Presenting information and responding to questions from groups of managers and clients/ customers