QA Specialist – 24/7 Manufacturing Oversight (Biotech)

BioSpace; Boca Raton (FL); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

401K plan with employer match

Medical Insurance

Vision Insurance

Life Insurance

Dental Insurance

Pet Insurance

STD and LTD

Holidays

Paid Time Off

Tuition Assistance

Job summary

ADMA Biologics in Boca Raton, FL is seeking a Specialist QA I – Manufacturing Oversight. The role conducts real-time batch record reviews, assesses manufacturing documentation, and ensures regulatory compliance on the plant floor.

The ideal candidate has 1–3 years in pharma/biotech, a Bachelor's degree, and a strong understanding of cGMP. The position offers 12-hour shift coverage and a comprehensive benefits package.

Qualifications

• Familiar with cGMP requirements and quality systems.
• Experience reviewing manufacturing documentation and events.
• Knowledge of regulatory guidelines (FDA) and CAPA processes.

Responsibilities

• Perform QA review and approval of real-time batch records.
• Inspect active production areas to ensure SOP compliance.
• Review and release plasma pools and raw materials in LIMS/SAP.
• Coordinate with QA management on additional projects.

Skills

Quality Systems

cGMP Compliance

Regulatory Knowledge

Documentation Review

Event Notifications

Education

Bachelor's Degree

Tools

LIMS

SAP

Job description

ADMA Biologics in Boca Raton, FL is seeking a Specialist QA I – Manufacturing Oversight. The role conducts real-time batch record reviews, assesses manufacturing documentation, and ensures regulatory compliance on the plant floor.

The ideal candidate has 1–3 years in pharma/biotech, a Bachelor's degree, and a strong understanding of cGMP. The position offers 12-hour shift coverage and a comprehensive benefits package.