QC Scientist, Medical Device & Pharma (GMP)

Plastikon Industries Inc; Lawrence (KS); Sur place; USD 55 000 - 75 000; Plein temps

Résumé du poste

Plastikon Healthcare is seeking a highly motivated and detail-oriented QC Scientist to join our GMP-compliant laboratory team. You will perform rigorous chemical, physical, and microbiological testing to ensure quality, safety, and efficacy of our medical devices and pharma products.

The ideal candidate holds a Bachelor's degree in a related science, 1–3 years of QC experience, and proficiency with pH, conductivity, TOC, bioburden and endotoxin testing.

Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, or related science.
• 1–3 years of QC laboratory experience in medical devices or pharmaceutical industry.
• Proficiency in pH, conductivity, and TOC analyses.
• Experience with FDA regulations, ISO 13485, and cGMP.
• Strong documentation, investigation, and problem-solving skills.

Responsabilités

• Perform chemical, physical, and microbiological testing per approved methods (HPLC, FTIR, TOC, pH, conductivity, endotoxin, bioburden, sterility).
• Record data contemporaneously in notebooks, worksheets, or electronic data systems in accordance with ALCOA+ principles.
• Review analytical data for accuracy before supervisory review.
• Support OOS/OOT investigations and CAPA activities.
• Maintain and calibrate laboratory instruments per schedule.
• Author, review, and update SOPs, test methods, and validations.
• 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.

Connaissances

HPLC

FTIR

TOC analysis

pH analysis

Conductivity analysis

Endotoxin testing

Bioburden testing

Sterility testing

Formation

Bachelor's degree in Chemistry/Biology/Microbiology

Outils

Electronic data systems

Description du poste

Plastikon Healthcare is seeking a highly motivated and detail-oriented QC Scientist to join our GMP-compliant laboratory team. You will perform rigorous chemical, physical, and microbiological testing to ensure quality, safety, and efficacy of our medical devices and pharma products.

The ideal candidate holds a Bachelor's degree in a related science, 1–3 years of QC experience, and proficiency with pH, conductivity, TOC, bioburden and endotoxin testing.