QA Specialist II, Manufacturing Oversight

ADMA Biologics; Boca Raton, Northern (FL, KY); Hybrid; USD 75,000 - 110,000; Full time

Benefits offered by this job

401K

Medical Insurance

Vision Insurance

Life Insurance

Dental Insurance

Pet Insurance

STD/LTD

Holidays

Paid Time Off

Tuition Assistance

Shuttle Service

Job summary

ADMA Biologics in Boca Raton, FL seeks a Specialist QA II Manufacturing Oversight to perform real-time batch review and oversight across active production areas. The role requires strong understanding of cGMP and regulatory standards, with 3–5 years in pharma/biotech and experience with QA documentation.

The QA team provides 24/7 manufacturing oversight with 12-hour shifts, and the candidate will help write and revise SOPs while coordinating with other departments to ensure compliance.

Qualifications

• Bachelor's degree preferred, offset by relevant experience.
• 3–5 years' experience in pharmaceutical/biotech or related industry.
• Experience with LIMS and SAP preferred.

Responsibilities

• Perform real-time batch record review and documentation checks.
• Review and release plasma pools and manufacturing docs.
• Maintain compliance with FDA regulations and SOPs.
• Oversee production areas to resolve issues and ensure policy adherence.
• Assist with QA SOPs, training, and cross-department feedback.

Skills

Quality Assurance

cGMP knowledge

Documentation

Regulatory compliance

Communication skills

Education

Bachelor's degree

Tools

LIMS

SAP

Job description

ADMA Biologics in Boca Raton, FL seeks a Specialist QA II Manufacturing Oversight to perform real-time batch review and oversight across active production areas. The role requires strong understanding of cGMP and regulatory standards, with 3–5 years in pharma/biotech and experience with QA documentation.

The QA team provides 24/7 manufacturing oversight with 12-hour shifts, and the candidate will help write and revise SOPs while coordinating with other departments to ensure compliance.