QA Oversight Specialist II – Biotech Manufacturing

BioSpace; Boca Raton (FL); On-site; USD 85,000 - 120,000; Full time

Job summary

ADMA Biologics is seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL. The role oversees real-time quality activities, reviews batch records and manufacturing documentation, and ensures adherence to SOPs and regulatory requirements.

Applicants should have 3–5 years in pharma/biotech, a Bachelor's degree preferred, and strong writing and communication skills. Knowledge of LIMS/SAP is a plus; FDA compliance is essential.

Qualifications

• Bachelor's degree preferred, or equivalent experience.
• 3-5 years' experience in pharmaceutical/biotechnology industries.
• Strong written and verbal communication and meticulous documentation.
• Knowledge of FDA regulations and cGMP practices.

Responsibilities

• Perform real-time batch record review and QA approvals.
• Review manufacturing documentation, logs, charts, and SOPs.
• Inspect active production areas to ensure SOP and policy compliance.
• Review and release plasma pools and raw materials in LIMS/SAP; perform Lookback disposition.
• Write, review, and revise QA SOPs; assist with training new staff.

Skills

Organizational skills

Communication skills

Education

Bachelor's degree preferred

Tools

LIMS

SAP

Job description

ADMA Biologics is seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL. The role oversees real-time quality activities, reviews batch records and manufacturing documentation, and ensures adherence to SOPs and regulatory requirements.

Applicants should have 3–5 years in pharma/biotech, a Bachelor's degree preferred, and strong writing and communication skills. Knowledge of LIMS/SAP is a plus; FDA compliance is essential.