QA Floor Inspector (I)

Job Description

The Quality Assurance Floor Inspector is the quality expert on the plant floor and is responsible for ensuring products are being produced in a manner that meets all Current Good Manufacturing Practice (cGMP) regulations and product specification criteria on the plant floor. This enables improved first pass quality and adherence to cGMPs on the production floor at all times.

Responsibilities include, but are not limited to:

• Conducts approval of pre-start-up activities including line/room clearance, and initial equipment checks
• Performs in-process testing verifications of operations data to confirm consistency in testing methodology and test data
• Reviews in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company Standard Operating Procedures (SOPs) and cGMP’s
• Discusses errors directly with line personnel so corrections can be made if required
• Confirms reconciliation/yield data for adherence to specifications and ensures that deviation reports are generated by responsible personnel if out-of-specifications are observed
• Reviews production logbooks for accuracy and compliance
• Provide real time guidance to line operations personnel pertaining to compliance to cGMP’s by monitoring dress code, documentation practices, testing methods, and testing accuracy
• Collects data on First Piece Qualification (FPQ)and performs release of batch records
• Performs daily compliance audit for responsible areas within production
• Responsible for conducting duties in compliance with safety rules, applicable SOP’s, and cGMP Guidelines

Qualifications

• Experience in the production process and/or environment is required
• Experience with production equipment functionality, Quality Assurance systems, and computer software, such as AS400, Captiva and PDM software, is preferred
• High school diploma or general education degree (GED) is required
• Excellent organizational, written and verbal communication skills is required
• Strong attention to detail
• Intermediate to advanced computer knowledge of MS Office programs (Outlook, Excel, Word) is required
• Understanding of mathematical functions, such as mean, median, average, and standard deviation is preferred
• Physical ability to repetitively lift (up to 30 lbs), stand, bend, climb, etc. within an operations environment is required