Quality Control Specialist

4 weeks ago


San Diego, California, United States BioPhase Solutions Full time
Job Overview

We are seeking a detail-oriented Quality Control Technician to join our reputable biotech diagnostic company. As a key member of our team, you will play a crucial role in ensuring the highest quality standards in our biotech diagnostic products.

Key Responsibilities
  • Perform routine and special inspections for visual, dimension, and functional assessments, ensuring adherence to inspection instructions.
  • Document and report inspection findings, monitoring corrective actions for any identified issues.
  • Execute product identification and traceability activities as required.
  • Review, approve, and maintain Device History Records for all manufacturing functions, in compliance with relevant standards and regulations.
  • Apply in-depth knowledge of QSRs/ISO and regulatory guidelines to daily tasks, ensuring quality standards are upheld.
  • Monitor and comply with customer specifications and company quality assurance policies.
  • Ensure proper calibration and maintenance of inspection equipment.
Essential Functions
  • Conduct and document hourly inspections.
  • Perform and document line clearance procedures.
  • Carry out First Articles and Retention Samples, documenting and filing accordingly.
  • Review, approve, and file documents for completeness and compliance.
Work Environment

The work environment encompasses warehouse, laboratory, and manufacturing settings, where handling viral and bacterial hazards, potentially hazardous chemicals, and infectious bodily fluids and samples may occur. Flexible work hours may be required to meet project deadlines.

Requirements
  • Minimum 6 months of Quality Control inspection experience required.
  • Experience with Good Manufacturing Practice (GMP)
  • Experience in a medical device high-volume manufacturing environment is strongly desired.
  • Ability to read, interpret, and follow detailed procedures, instructions, and drawings.
  • Solid understanding of QSRs/ISO standards.
  • Demonstrated team-oriented interaction skills and professional behavior.
  • Proficiency in word processing, data entry, and spreadsheet navigation.
  • Familiarity with basic quality terms, definitions, and concepts.
  • Understanding of traceability (product, material, and calibration).
  • Basic math skills for determining appropriate sample sizes for inspection based on lot sizes.
  • Problem-solving skills to identify processes and standards in need of improvement and initiate appropriate action.


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