Batch Records Auditor

Fresenius Kabi USA • Wilson, NC

1d

About The Position

This position conducts analyses and inspections of raw and packaged materials, executes quantitative and qualitative assays, and ensures adherence to quality standards and regulatory compliance for manufactured products. The Specialist performs various accountabilities including performing analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property. This also involves performing a variety of qualitative tests or qualitative assays on samples to aid in maintenance and certification of test instruments and apparatus to ensure compliance, performing required inspections, checks, analysis and documentation of studies, preparing and monitoring quality statistics and reports, reviewing production records for conformance to procedures, and evaluating non-conforming results and initiating re-sampling, re-testing, and/or hold procedures.

Requirements

• Ability to conduct analyses and inspections of raw and packaged materials
• Ability to execute quantitative and qualitative assays
• Knowledge of quality standards and regulatory compliance for manufactured products
• Ability to perform tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products
• Ability to maintain and certify test instruments and apparatus
• Ability to perform inspections, checks, analysis and documentation of studies
• Ability to prepare and monitor quality statistics and reports
• Ability to review production records for conformance to procedures
• Ability to evaluate non-conforming results and initiate re-sampling, re-testing, and/or hold procedures

Responsibilities

• Performing analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property
• Performing a variety of qualitative tests or qualitative assays on samples to aid in maintenance and certification of test instruments and apparatus to ensure compliance
• Performing required inspections, checks, analysis and documentation of studies
• Preparing and monitoring quality statistics and reports
• Reviewing production records for conformance to procedures
• Evaluating non-conforming results and initiating re-sampling, re-testing, and/or hold procedures

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed