Quality Assurance Inspector I

4 weeks 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. The successful candidate will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities:

  • Inspect works in-process and finished goods to ensure conformance to ISO 13485:2016, FDA regulated standards, customer specifications, and Argen requirements.
  • Perform visual inspections of finished products and maintain proper inspection and test records.
  • Participate in internal assessments and audits as required.
  • Assure that non-conforming material has been properly identified and advise production personnel of the acceptability of products or materials based on results of testing and/or inspection.
  • Provide solutions to technical problems and assist on special projects.
  • 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.
  • Ensure that lab cleanliness and safety standards are maintained.
  • 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.
  • Ensure that production lines are properly cleared and prepared for the next production run, maintaining cleanliness and order.
  • Examine and validate DHRs to ensure all documentation is complete, accurate, and in compliance with regulatory and company standards.

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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