Manufacturing QA Oversight Specialist II

ADMA Biologics, Inc.; Boca Raton (FL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

401(k) with employer match

Medical insurance

Vision insurance

Life insurance

Dental insurance

Paid holidays

Job summary

ADMA Biologics, Inc. is seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL. The role focuses on real-time batch record review, documentation reviews, and issue resolution on the manufacturing floor to ensure GMP compliance.

The candidate will perform QA oversight, maintain compliance with 21 CFR Parts 11, 210, 211, and 600, and support investigations, CAPAs, and deviations as required. Eligible applicants should have 3–5 years in pharma/biotech and a Bachelor’s degree or

Qualifications

• 3–5 years of experience in pharmaceutical or biotechnology industry.
• Bachelor's degree preferred.
• Knowledge of FDA regulations and GMP.
• Experience with LIMS and SAP is a plus.

Responsibilities

• Perform manufacturing oversight to ensure compliance with policies and procedures.
• Review Deviation Reports and QA documentation.
• Maintain knowledge of 21 CFR Parts 11, 210, 211, and 600.
• Oversee production areas to ensure SOP compliance.

Skills

Quality Assurance

Regulatory compliance

Documentation

cGMP knowledge

Communication skills

Education

Bachelor's degree

Tools

LIMS

SAP

Job description

ADMA Biologics, Inc. is seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL. The role focuses on real-time batch record review, documentation reviews, and issue resolution on the manufacturing floor to ensure GMP compliance.

The candidate will perform QA oversight, maintain compliance with 21 CFR Parts 11, 210, 211, and 600, and support investigations, CAPAs, and deviations as required. Eligible applicants should have 3–5 years in pharma/biotech and a Bachelor’s degree or