Quality Auditor

Job Summary

The role is essential in ensuring in-process and finished products meet customer specifications. This role provides total manufacturing quality inspection services including quality inspection, quality control, sampling inspection, documentation and record keeping. Adhering to Good Documentation Process (GDP) is essential to maintain all documentation necessary to ensure conformity to specifications and traceability of records.

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Essential Duties and Responsibilities

• Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable.
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site.
• Understand and follow applicable ISO standards requirements.
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices.
• Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary.
• Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System.
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site.
• Generate rejection and deviation reports as directed by site.
• Perform trace back investigation of nonconforming raw material and product as directed by site.
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

Education

• High school diploma or GED required.
• Associate degree in Science, Math, or related field preferred.

Work Experience

• No minimum required.
• 1+ year in a cGMP environment or related field preferred.

Preferred Knowledge, Skills and Abilities

• ANSI, AQL, ShopFloor experience preferred.
• Must possess an acute attention to detail.
• Basic computer skills.

Travel Requirements

Physical Requirements