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Quality Control Inspector
Career Insights for Quality Control Analyst
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Based on California data
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$67,470 / year median in California
-12% projected decline
Job Description
- Perform incoming, first article, in-process, final, pre-irradiation, and post-irradiation inspections on materials, parts, and finished products.
- Document inspection results, complete required quality records, and ensure procedures are followed accurately and consistently.
- Initiate nonconformance reports for non-conforming materials or process findings and support related cross-functional investigations.
- Approve or reject raw materials based on quality standards and communicate results to appropriate internal teams.
- Review and release job order documents while supporting GMP, ISO, and regulatory compliance requirements.
- Maintain safe, clean, and compliant work areas, including proper PPE use in ISO-controlled environments. Compensation and Benefits
- $24.00 to $25.00 per hour.
- Direct hire opportunity. Required Qualifications and Skills
- Perform quality inspections across incoming, in-process, final, and irradiation-related production stages.
- Initiate and document nonconformance reports and support corrective action investigations.
- Review quality documentation, job order records, and inspection results for accuracy and compliance.
- Support continuous improvement initiatives within a regulated manufacturing environment.
- High school diploma or equivalent required.
- Minimum 3 years of quality control inspection experience.
- 1+ years of experience with technical documentation, quality inspections, and corrective actions in a pharmaceutical or medical device manufacturing environment.
- Understanding of GMP operations, detailed SOPs, and good documentation practices.
- Knowledge of ISO 9001 and/or
ISO 13485
2003, 21 CFR Parts 210 and 211, and/or 21 CFR Part 820.- General knowledge of measuring devices such as calipers, tape measures, rulers, and pin gauges.
- Good computer skills and working knowledge of ERP systems.
- Strong organizational, planning, written communication, and verbal communication skills.
- Ability to work effectively in a team environment and communicate across departments, vendors, and customers.
- Strong attention to detail, sound judgment, integrity, and an uncompromising commitment to quality.
- Good general mathematical skills.
- Ability to wear required PPE in an ISO environment, including scrubs, coverall suit, mask, protective eyewear, gloves, shoe covers, and similar protective items. Preferred Qualifications
- Experience using Syteline ERP.
- Prior quality control experience in biotechnology, pharmaceutical, or medical device manufacturing.
- Familiarity with regulated cleanroom or ISO-controlled production environments.