QA Specialist (Pharma/Biotech)

Hello

Hope you are doing well.

This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at 1(732)-276-1791

Job Title: QA Specialist

Location: Harmans, MD (Onsite)

Job Overview

The QA Specialist will provide Quality Assurance (QA) support for GMP manufacturing, focusing on the production of master/working cell banks, bulk drug substances, and finished drug products. This role involves working closely with manufacturing operations, ensuring compliance with industry standards, regulatory guidelines, and quality improvement efforts.

Key Responsibilities

• QA oversight on the manufacturing floor (75% of time spent on the floor).
• Room release, batch documentation review, and critical process observation.
• Visual inspection of drug products and reviewing buffer prep solutions.
• Document and resolve manufacturing issues in real time.
• Ensure compliance with GMPs and internal procedures.
• Participate in audits and continuous improvement initiatives.
  
  

Requirements

• Bachelor’s degree in Science, Engineering, Biotech, or related field.
• 0-2 years of experience in QA, QC, or manufacturing in biologics or regulated industries.
• Knowledge of GMP, 21 CFR regulations, and biological manufacturing processes.