QA Operations Associate I New Albany, OH

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Unless specifically stated otherwise this role isOn-Site at the location detailed in the job post.

Nature and Scope

This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

Achieve and maintain packaging line and inspection room clearance qualification
Conduct accurate verifications and checks as well as accurate process inspections
Conduct accurate packaging AQL inspections
Identify out of specification product ensuring segregation and escalation as required
Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements
Ensure all work is performed and documented in accordance with existing Company policies and procedures as well as cGMP health and safety requirements.
Conduct component and raw material release
Conduct chart monitoring ensuring escalation as required
Support product shipping activities and perform quality related oversight and verifications
Generate logbooks and sheets/labels
Review Bills of Materials
Basic knowledge of cGMPs and supporting regulatory documents
Achieve and maintain clean side gown and sterile side gown qualifications
Achieve and maintain Class A qualification
Perform room area and equipment clearances.
Participate in Media Fill and maintain qualification
Able to perform tasks with minimal error rate.
Perform any other tasks/duties as assigned by management.