Quality Assurance Inspector I

2 days ago

San Diego, California, United States Argen Corporation Full time
Job Summary

Argen Corporation is seeking a Quality Assurance Inspector I to join our team. As a Quality Assurance Inspector I, you will play a pivotal role in ensuring the quality and integrity of our products.

In this role, you will be responsible for inspecting works in-process and finished goods in manufacturing areas to ensure conformance to ISO 13485:2016, FDA regulated standards, customer specifications, Argen requirements, and applicable procedures.

You will provide in-process/final inspection and testing as required, perform visual inspections of finished products, participate in internal assessments and audits as required, and maintain proper inspection and test records.

You will also assure that non-conforming material has been properly identified, advise the responsible production personnel of the acceptability of products or materials based on results of testing and/or inspection, and provide solutions to technical problems and assist on special projects.

Additionally, you will maintain lot traceability, log sheets, and good housekeeping practices at all times, maintain a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner, and ensure that lab cleanliness and safety standards are maintained.

You will perform thorough inspections during and after the production process to ensure product quality and compliance with standards, verify that all product labeling is accurate, compliant, and meets regulatory requirements, and ensure that production lines are properly cleared and prepared for the next production run, maintaining cleanliness and order.

You will also examine and validate DHRs to ensure all documentation is complete, accurate, and in compliance with regulatory and company standards, and perform other duties as assigned.

Requirements

  • High school diploma or equivalent required.
  • Previous experience working in a GMP facility a plus.
  • 8 hours of Quality Training (PTC) required.
  • Strong attention to detail.
  • Knowledge of basic arithmetic and application to solve problems.
  • Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
  • Knowledge of computer skills, administrative and office procedures and systems.
  • Communicating effectively in writing as appropriate for the needs of the audience.
  • Technical skills and ability to understand drawings, artworks and procedures.
  • Talking to others to convey information effectively.
  • Perform duties with the highest regard for safety and quality.
  • Ability to understand and follow site protocols, policies and procedures.
  • Must be flexible, forward-thinking, motivated, and have the ability to act independently.
  • Ability to prioritize tasks and meet deadlines.
  • Problem-solving skills.
  • Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training.
  • Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.

Benefits

  • Health Plans.
  • Dental Plans.
  • Vision Plan.
  • 401k with Employer Match.
  • Paid Time Off and Paid Holidays.
  • Employee Events.
  • Wellness Programs.
  • Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more.

EOE/M/F/Vet/Disabled VEVRAA Federal Contractor

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