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Specialist, Quality Control
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
Your Role:
The Quality Control Specialist is an individual contributor who works within the QC Stability team. Dedicated to supporting cross-functional teams and driving continuous improvement within the stability program to maintain high standards of quality and regulatory readiness.Key Responsibilities:
Assist in stability sample pulls at each timepoint Oversee proper storage, handling, and inventory of stability samples in temperature-controlled chambers Prepare/aliquot R D stability samples Assist in Reference Standard Generation activities Generate weekly stability status reports for management using Excel Independently manage competing priorities with limited instruction Collaborate with management to establish and meet targets and timelines by providing weekly forecasts Identify and recommend solutions to potential procedure, process and system gaps Maintain and track stability QC testing documentation (STWs and QC test method forms) Review documentation from theQCA, QCM
departments and 3rd party vendors Compile data for Stability Summary of Testing reports (SofT's) Prepare Stability Summary of Testing reports, Certificates of Analysis, and Statements of Testing Identify opportunities to optimize stability workflows and contribute to process improvement initiatives Support internal and external audits Perform other duties as requested by management to support quality activities Maintain the quality compliance of all QC operational areas Ensure and apply GMP throughout operationsQC Stability Sample Lifecycle Maintenance:
Prepare- STW/LIMS/label generation Aliquot
- sterile aliquoting of samples into assay specific individually labeled tubes Ship/Track
- track samples weekly to maintain on-time target delivery Dispose
- coordinate sample inventory and disposition
Position Type/Expected Hours of Work:
This role is a full-time onsite position. Days and hours of work are Monday through Friday unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.Compensation:
We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off. The compensation range for this role is $32.30- $40.