Quality Technician

3 weeks ago

Randolph New Jersey, United States Praxis Packaging Full time
Overview:
If you’re looking for a new company to grow your skills, then Praxis Packaging Solutions/ Unette Corporation may be the place for you.  Praxis is an FDA-compliant packaging organization specializing in primary tablet filling of OTC & Rx packaging with industry-best serialization capabilities. We value quality, customer service, and safety, and the opportunities that come with problem solving in this fast-paced facility will allow you to boost your personal development.  Employees at Praxis are from all over the world, and diversity in the workplace is respected and celebrated.  We offer two health insurance options, dental, vision, flex, and company paid short term disability, long term disability and life insurance.  We invest in our employees and provide a 4% 401k employer match.  Apply today if you are interested in joining a dynamic team in the pharma industry.

 

 

Responsibilities:
 

The Quality Technician is responsible for assisting Quality management in the daily administration of the Quality department. Support in-process inspectors and end lot inspectors to complete tasks as required.

 

Perform Incoming Inspection for received components and film.

Perform In-process and end lot inspection for compliance with customer specification.

Perform sampling (AQL) testing and evaluation as required to assure product quality.

Perform Internal calibration and coordinate external calibrations for all equipment on site.

Generate customer Notification of Quality Issue (CNQI) report.

Manage Inventory for Quality supplies.

Assist with execution of cleaning Verification/Validation for primary fill packaging operations per established Standard Operating Procedures (SOPs).

Assist with execution of filling Verification for primary fill packaging operations per established Standard Operating Procedures (SOPs).

Support Management with incident and/or deviation, by investigating, documenting, and escalating issues as appropriate to the team.

Monitor daily facility temperature for compliance and generate monthly reports.

Review all CAPA for completion and verify all effectiveness checks.

Train new In-process and end lot inspectors

Qualifications:
High school diploma or equivalent required, Associates Degree or equivalent combination preferred

2 or more years in a Quality or highly regulated focused role required.

Basic written and mathematical aptitude required.

The ability to work independently, without supervision required.

Ability to organize priorities and workload required.

Demonstrated ability in customer service.

3 years working with flexible packaging or tubing preferred.

Experience filling liquids into bottles a plus.

Working knowledge of MS Office programs: Word, Excel, and Outlook, preferred

Working knowledge of Enterprise Resource Planning (ERP) related software, preferred

Ability to comprehend and follow written English instruction and specifications, required

Basic comprehension of the English language: reading and writing skills to understand and complete necessary paperwork, required.

Bilingual fluency in Spanish is strongly preferred.

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