QA Oversight Specialist - Biopharma Manufacturing

BioSpace; Boca Raton (FL); Sur place; USD 80 000 - 100 000; Plein temps

Avantages offerts par ce poste

401K plan with employer match and vest

Medical, Vision, Life and Dental

Pet Insurance

Company paid STD and LTD

Holidays

3 Weeks’ Paid Time Off

Tuition Assistance

Free shuttle to Boca Tri-Rail

Résumé du poste

ADMA Biologics in Boca Raton, FL is seeking a QA Specialist II Manufacturing Oversight to ensure compliance across manufacturing operations. The role involves real-time batch review, documentation control, and escalation of deviations in a 24/7 environment with 12-hour shifts.

Ideal candidates have 3–5 years in pharma/biotech, a Bachelor's degree, and strong knowledge of cGMP, CAPAs, Change Controls, and LIMS/SAP. Join a growing biopharma focused on patient safety and regulatory excellence.

Qualifications

• 3–5 years of pharmaceutical or biotechnolog y industry experience.
• Bachelor's degree preferred; experience may offset.
• Strong writing and oral communication skills.
• Knowledge of FDA regulations and GMP.

Responsabilités

• Perform real-time batch record review and QA approvals.
• Review manufacturing documentation (logs, charts) and records.
• Oversee production areas to ensure SOP compliance.
• Review and release plasma pools and raw materials in LIMS/SAP.
• Assist with QA SOPs writing and training.
• Coordinate with QA Management on projects.

Connaissances

Quality Systems

CAPAs

Change Controls

OOSs

cGMP

SOPs

Documentation

Regulatory compliance

Formation

Bachelor's degree

Outils

LIMS

SAP

Description du poste

ADMA Biologics in Boca Raton, FL is seeking a QA Specialist II Manufacturing Oversight to ensure compliance across manufacturing operations. The role involves real-time batch review, documentation control, and escalation of deviations in a 24/7 environment with 12-hour shifts.

Ideal candidates have 3–5 years in pharma/biotech, a Bachelor's degree, and strong knowledge of cGMP, CAPAs, Change Controls, and LIMS/SAP. Join a growing biopharma focused on patient safety and regulatory excellence.