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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.