Quality Assurance Tech
NicePak Products Inc./ PDIAbout the role
Nice-Pak Products, Inc. (NP) is the global developer, manufacturer and marketer of pre-moistened wipes for the consumer market, specializing in personal care, hygiene, household cleaning and disinfection products.
We have several locations across the US and are looking for new Associates to join our team!
This position is a 8 hour 3rd shift - 10:00 pm to 6:00 am.
We offer an amazing company culture, training and development opportunities, a competitive offering, as well as opportunities for growth and advancement. Benefits start Day One!!
Requirements
POSITION PURPOSE
This is a safety sensitive position.
The Quality Assurance Technician interacts with the Analytical and Microbiology Technicians, Production, Warehouse, Compounding, Engineering, and Maintenance to facilitate the development and maintenance of quality systems. This position is responsible for the following.
- assuring that incoming raw materials and finished goods are being sampled in conformance with established specifications and procedures and in accordance with regulatory requirements.
- assuring all documentation is routed, distributed, and filed in accordance with procedure and regulatory requirements
- assuring all products being manufactured are in conformance with established specifications, procedures and in accordance with regulatory requirements.
- Assuring there is support for trials and other projects when needed
ESSENTIAL KSA’S (KNOWLEDGE, SKILLSET AND ABILITIES)
This position is responsible for assuring that the documentation, materials being used, and products being manufactured are in conformance with established specifications, procedures and in accordance with regulatory requirements. The position also provides technical support for Operations leadership and Machine Operators in implementing Statistical Process Control and in maintaining a system of line / machine checks, inspection of incoming materials and finished products, internal audits and in the completion of appropriate documentation. A key responsibility of this position is the identification of nonconforming products or processes, and leadership in continuous improvement efforts. The QA Tech must also possess the knowledge, skills and abilities to complete the following essential job functions and responsibilities:
- Complete daily inspections of all production lines to ensure compliance to Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOP’s).
- Verify Operator Execution of routine Quality Inspections and tasks as required on DIR’s
- Perform routine Job Jacket inspections as required to ensure all documentation is complete, accounted for, and compliance to GDP.
- Provide GMP, GDP coaching to operators.
- Ensure that all manufacturing specifications are correct, clear and complete.
- Audit cleanliness of machinery and operator’s attire.
- Sample, inspect and test in-process, finished products, returned and reworked material for quality. Determine final disposition on inspected products. Apply appropriate disposition label (via physical and virtual warehouse management systems) to material.
- Accurately and completely document all inspection information on Daily Inspection Report (DIR).
- Ensure raw materials are appropriately identified, tested and released before use in production
- Maintain computer data systems to reflect product release/quarantine status.
- Ensure that all finished goods are identified and released according to cGMP’s and Nice Pak SOP’s and Work Instructions (WI’s).
- Support the development and use of Acceptable Quality Limits (AQL’s), as well as train Operations leadership and Machine Operators on AQL and trouble-shooting techniques as required.
- Facilitate the maintenance of documentation and tracking of nonconforming and rejected material.
- Notify and follow through with production and Quality when variations from procedures and specifications are observed. This function includes identifying non-conforming material, recording of it and distributing required documentation.
- Collect samples as required by customers or Nice Pak’s specifications. This includes any retain sampling as per manufacturing specifications and QC sample submission.
- Handle assignments as requested to establish and maintain product quality.
- Perform any required testing as per SOPs and WI’s.
- Provide support to Production in all Quality efforts
- Maintain accurate, complete and traceable documentation of raw materials. Keep accurate paperwork on any finished goods or raw materials inspected.
- Complete physical and graphics inspections of raw material samples as needed to support operations.
- Generate R
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