Quality Control Scientist

Plastikon Healthcare is seeking a highly motivated and detail-oriented QC Scientist to join our dynamic medical device/pharmaceutical laboratory team. In this pivotal role, you will be responsible for ensuring the quality, safety, and efficacy of our products through rigorous testing and analysis. Your expertise in analytical chemistry, laboratory techniques, and regulatory compliance will help uphold our commitment to excellence in medical device and pharmaceutical development.

This position offers an exciting opportunity to contribute to production processes within a fast-paced, GMP-compliant environment.

• Perform chemical, physical, and microbiological testing per approved methods (HPLC, FTIR, TOC, pH, conductivity, endotoxin, bioburden, sterility and other microbial and wet chemistry tests).
• Record all test data contemporaneously in laboratory notebooks, worksheets, or electronic data systems in accordance with ALCOA+ data integrity principles.
• Review and verify analytical data for accuracy, completeness, and compliance before submitting for supervisory review.
• Support OOS/OOT investigations and CAPA activities.
• Maintain and calibrate laboratory instruments per schedule.
• Author, review, and update standard operating procedures (SOPs), test methods, method validations and other QC documentation.
• Support internal and external audits (FDA, ISO, customer).
• Ensure compliance with cGMP, GLP, FDA 21 CFR Parts 210/211/820, and ISO 13485.
• Collaborate with Manufacturing, R&D, and Regulatory teams on quality issues.

• Bachelor's degree in Chemistry, Biology, Microbiology, or related science
• 1-3 years of QC laboratory experience in medical device, pharmaceutical or related industry setting
• Proficiency in pH, conductivity, and TOC analysis, bioburden and endotoxin
• Experience in chemistry preferred.
• Working knowledge of FDA regulations, ISO 13485, and cGMP requirements
• Strong documentation, investigation, and problem-solving skills