Biologics Manufacturing QMS Specialist

Kashiv Biosciences LLC; Chicago (IL); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

FSA

HSA

Commuter/Transit Benefits

Student Loan Assistance Program

Monthly Cell Phone Allowance

Free Parking (Company Paid)

Conveniently located next to the Metra, Green and Red Line

Near Chicago White Sox Stadium

< 10 minutes away from Downtown Chicago

Job summary

Kashiv Biosciences LLC is seeking a Manufacturing QMS Specialist for a full-time position in Chicago, IL. The role involves supporting the manufacturing team with documentation, including reviewing batch records and filing change controls. Candidates should have at least a BA/BS in Biological Sciences and a minimum of 5 years of experience in biopharmaceuticals, along with strong communication and interpersonal skills. Benefits include medical, dental, vision, 401K, and more.

Qualifications

• Minimum BA or BS in Biological Sciences or related technical field is required.
• Minimum 5 years of experience in Biopharmaceuticals.
• Knowledge in USP and DSP process.

Responsibilities

• Support the manufacturing team with documentation work.
• Review batch records and file change controls.
• Use investigation tools for critical investigations.
• Attend daily meetings for documentation requirements.
• Meet weekly with QA to ensure timely QMS closure.
• Author batch records and related forms.
• Submit GMP documents to QA.

Skills

Interpersonal Skills

Communication Skills

Detail-oriented

Basic Computer Skills

Knowledge of GMP Documentation

Cleaning Verification/Validation Knowledge

Education

BA or BS in Biological Sciences or related field

5 years of experience in Biopharmaceuticals

Tools

Microsoft Word

Microsoft Excel

Job description

Kashiv Biosciences LLC is seeking a Manufacturing QMS Specialist for a full-time position in Chicago, IL. The role involves supporting the manufacturing team with documentation, including reviewing batch records and filing change controls. Candidates should have at least a BA/BS in Biological Sciences and a minimum of 5 years of experience in biopharmaceuticals, along with strong communication and interpersonal skills. Benefits include medical, dental, vision, 401K, and more.