QA Floor Inspector (I)
Employment Type: Full-Time
Industry: Information Technology
The QA Floor Inspector is responsible for ensuring products are being produced in a manner that meets all current Good Manufacturing Practices (cGMPs) and Product Specification criteria. This enables improved first pass quality and adherence to cGMPs on the production floor at all times. The position is part of the Quality Unit on the plant floor and provides real time review of in-process test data and batch documentation in order to limit the need for later review or rework. Also, the Inspector acts as the quality expert on the production floor and will guide and advise operation associates, as needed, on cGMP's and Good Documentation Practices (GDPs) to ensure timely release of product or reaction to issues.
Additional responsibilities include, but are not limited to:
- When required, conducts approval of pre-start-up activities including line/room clearance, and initial equipment checks.
- When required, performs in-process testing verification's of operations data to confirm consistency in testing methodology and test data.
- Consistently reviews in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company SOP's 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 FPQ and performs release of batch records.
- Complies with company policies and procedures and maintains exceptional work attendance.
- Performs daily compliance Audit for responsible areas within production.
- Conducting duties in compliance with safety rules, applicable SOP's, and cGMP Guidelines.
- Experience in the production process and/or environment
- Experience with production equipment functionality, Quality Assurance Systems, and computer software, i.e. AS400, Captiva and PDM
- Strong organizational skills, written, oral, interpersonal attention to detail skills
- Intermediate to advanced computer knowledge of MS Office programs (Outlook, Excel, Word)
- Understanding of mathematical functions, such as mean, median, average, and standard deviation is preferred
- Physical ability to repetitively lift (up to 30 pounds), stand, bend, climb, etc. within an operations environment
Associated topics: performance test, process, prevent, quality assurance analyst, quality assurance lead, software quality, software quality assurance, software quality engineer, test, tester
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