QMS Specialist I — Quality Systems for Biologics

Kashiv BioSciences, LLC; Chicago (IL); On-site; USD 60,000 - 65,000; Full time

Benefits offered by this job

Medical Insurance - Aetna

401K

Free Parking (Company Paid)

Monthly Cell Phone Allowance

Metra/Transit nearby

Job summary

Kashiv BioSciences, LLC seeks a QMS Specialist I, QA in Chicago to maintain the quality management system across QA oversight for late-stage clinical and commercial biosimilar manufacturing. Responsibilities include managing deviations, CAPAs, change controls, and investigations, with emphasis on data integrity and regulatory compliance.

The role requires 1–3 years in QA/GMP environments, a life sciences degree, and strong documentation and cross-functional collaboration skills.

Qualifications

• Bachelor / master’s degree in Life Science, biotechnology, pharmacy or microbiology or related discipline.
• 1-3 years of relevant QA or GMP-regulated pharma/biotech experience.
• Familiarity with Deviations, CAPAs, Change Controls, OOS investigations, and quality risk management.

Responsibilities

• Maintain Quality Management System records including Deviations, Nonconformances, CAPAs, Change Controls, OOS/OOT Investigations, Complaints, and Risk Assessments.
• Ensure timely initiation, investigation, and closure of quality events per procedures.
• Coordinate cross-functional investigations and drive action items to closing.
• Review investigations for completeness, scientific rationale, data integrity, and effectiveness of CAPAs.
• Support quality risk management activities and monitor Quality System performance metrics.
• Prepare trending reports and management review data related to quality indicators.

Skills

Quality Assurance

GMP compliance

Regulatory compliance

Root cause analysis

Documentation skills

Cross-functional collaboration

Analytical skills

Education

Bachelor / master’s degree in Life Science or biotechnology or pharmacy or microbiology or related discipline

Tools

Quality Management Software

Job description

Kashiv BioSciences, LLC seeks a QMS Specialist I, QA in Chicago to maintain the quality management system across QA oversight for late-stage clinical and commercial biosimilar manufacturing. Responsibilities include managing deviations, CAPAs, change controls, and investigations, with emphasis on data integrity and regulatory compliance.

The role requires 1–3 years in QA/GMP environments, a life sciences degree, and strong documentation and cross-functional collaboration skills.