Quality Control (QC) Scientist

Job Description

Salary:

Position Title: Quality Control (QC) Scientist

Department: Quality Control / Quality Assurance

Reports To: QC Manager / Chief Operating Officer

Position Summary

The QC Scientist supports the development, manufacture, and release of In Vitro Diagnostic (IVD) products by performing quality control testing, method validation, and documentation in compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, and other applicable regulatory requirements. This role ensures that all diagnostic products meet rigorous quality standards for accuracy, reliability, and safety prior to release.

Key Responsibilities

Perform QC testing on raw materials, intermediates, and finished IVD products, including reagents, controls, and kits, using established protocols (e.g., immunoassays, PCR, molecular diagnostic methods, spectrophotometry).

Execute method validation, verification, and transfer for analytical and functional assays in compliance with CLSI and regulatory guidelines.

Support stability studies, shelf-life testing, and lot-to-lot consistency evaluations for diagnostic products.

Maintain accurate and compliant documentation in accordance with ISO 13485, IVDR, and GMP/GLP requirements.

Investigate out-of-specification (OOS), out-of-trend (OOT), and nonconformance events; contribute to root cause analysis and CAPA implementation.

Collaborate with R&D, Production, and QA to support new product introduction, technology transfer, and process improvements.

Participate in internal audits, regulatory inspections (FDA, ISO, Notified Body), and quality system reviews.

Provide technical training and guidance to QC Analysts and laboratory staff.

Ensure laboratory equipment is calibrated, qualified, and maintained according to quality standards.

Qualifications

Bachelors or Masters degree in Biology, Biochemistry, Molecular Biology, Biotechnology, or related life science discipline.

15+ years of quality control experience in an IVD, medical device, or regulated diagnostic manufacturing environment.

Hands-on experience with relevant analytical methods (e.g., qPCR, spectrophotometry, electrophoresis).

Strong knowledge of regulatory requirements: ISO 13485, FDA QSR (21 CFR Part 820), IVDR (EU 2017/746), CLSI guidelines.

Familiarity with GMP, GLP, and good documentation practices (GDP).

Proficiency in data analysis and use of laboratory software systems (LIMS, qPCR data analysis, chromatography software, etc.).

Strong organizational, troubleshooting, and problem-solving skills.

Effective written and verbal communication skills; ability to work collaboratively across functions.

Preferred Skills

Experience with diagnostic assay validation (sensitivity, specificity, accuracy, precision, robustness).

Prior experience supporting regulatory submissions or audits (FDA, ISO, Notified Body).

Knowledge of risk management principles (ISO 14971) and design control processes.

Familiarity with statistical analysis tools for QC data trending.

Working Conditions

Laboratory-based position with regular handling of biological samples, reagents, and chemicals.

May require occasional work outside normal business hours to support production timelines.

Strict adherence to laboratory safety and biosafety protocols is required.

Full-time