QC Scientist Plastikon Healthcare - 2.1 Lawrence, KS Job Details Full-time $65,000 - $85,000 a year 4 hours ago Benefits Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance 401(k) matching Life insurance Qualifications Biology pH level monitoring pH meters Bachelor's degree Medical device manufacturing facility experience Attention to detail Regulatory/legal compliance standards in production Biomedical regulatory compliance Quality control experience within pharmaceutical industry Quality audits

ISO 13485 FDA

regulations Full Job Description Header Job Overview 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. Duties 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 c

GMP, GLP, FDA 21 CFR

Parts 210/211/820, and

ISO 13485.

Collaborate with Manufacturing, R D, and Regulatory teams on quality issues. Qualifications 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 ASQ CQE or CQA certification preferred #

PKJOBS Pay:

$65,000.00 - $85,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person