QA Manufacturing Oversight Specialist - 12-Hour Shifts

BioSpace; Boca Raton (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401K plan with employer match

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

STD and LTD

Paid Holidays

PTO (3 weeks)

Job summary

ADMA Biologics in Boca Raton, FL is seeking a Specialist QA I Manufacturing Oversight to ensure compliance with quality systems through real-time batch record review and review of manufacturing documentation.

The role involves inspecting production areas, releasing plasma pools, and ensuring adherence to SOPs and regulations (21 CFR 11, 210, 211, 600). It requires 1–3 years in pharma/biotech and a Bachelor’s degree; 12-hour shifts and 24/7 coverage rotation.

Qualifications

• Bachelor’s degree required or equivalent experience in pharmaceutical/biotech
• 1–3 years’ experience in pharma/biotech preferred
• Strong attention to detail and regulatory compliance

Responsibilities

• Perform real-time manufacturing batch record review and approval
• Review manufacturing documentation (logs, charts, etc.) for compliance
• Resolve issues on the manufacturing floor and ensure SOP adherence
• Review and release plasma pools to manufacturing
• Audit nitrogen receipt process and other material controls
• Coordinate with QA Management and support 24/7 oversight rotations

Skills

Quality Systems

cGMP compliance

Documentation review

Education

Bachelor's Degree

Tools

LIMS

SAP

Job description

ADMA Biologics in Boca Raton, FL is seeking a Specialist QA I Manufacturing Oversight to ensure compliance with quality systems through real-time batch record review and review of manufacturing documentation.

The role involves inspecting production areas, releasing plasma pools, and ensuring adherence to SOPs and regulations (21 CFR 11, 210, 211, 600). It requires 1–3 years in pharma/biotech and a Bachelor’s degree; 12-hour shifts and 24/7 coverage rotation.