12-Hour QA Oversight Specialist - Biotech

ADMA Biologics; Boca Raton (FL); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

401K with employer match

Medical, Vision, Life and Dental

Pet Insurance

STD/LTD

Paid Holidays

Paid Time Off

Tuition Assistance

Free shuttle to Tri-Rail

Job summary

ADMA Biologics is seeking a QA II Manufacturing Oversight Specialist in Boca Raton, FL. The role involves real-time batch record review, documentation checks, and ensuring compliance with cGMP and FDA regulations. The team provides 24/7 coverage, with 12-hour shifts.

The ideal candidate has 3–5 years in pharma/biotech, a Bachelor’s degree, and experience with quality systems, CAPAs, and change controls. Strong attention to detail and written communication are essential.

Qualifications

• Bachelor's degree preferred, with relevant experience in pharma/biotech.
• 3–5 years' experience in pharmaceutical/biotech industry or similar.
• Understanding of FDA regulations and quality systems.

Responsibilities

• Perform real-time manufacturing batch record reviews and approval of deviation reports.
• Review manufacturing documentation and ensure compliance with SOPs and policies.
• Oversee active production areas to resolve issues and ensure compliance with regulations.
• Review and release plasma pools and raw materials in LIMS/SAP.
• Assist with QA SOPs and cross-department feedback; participate in CAPA/Change Control activities.

Skills

Quality Systems

CAPAs

OOSs

cGMP

21 CFR 11

Regulatory Compliance

LIMS

SAP

Education

Bachelor's Degree

Tools

LIMS

SAP

Job description

ADMA Biologics is seeking a QA II Manufacturing Oversight Specialist in Boca Raton, FL. The role involves real-time batch record review, documentation checks, and ensuring compliance with cGMP and FDA regulations. The team provides 24/7 coverage, with 12-hour shifts.

The ideal candidate has 3–5 years in pharma/biotech, a Bachelor’s degree, and experience with quality systems, CAPAs, and change controls. Strong attention to detail and written communication are essential.