Impact-Driven QA: Manufacturing Oversight Specialist II

BioSpace; Boca Raton (FL); In loco; USD 85.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

401K with employer match

Medical, Vision, Life and Dental Ins.

Pet Insurance

STD and LTD (Company paid)

Company Holidays

Descrizione del lavoro

ADMA Biologics is seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL. The role ensures real-time QA oversight, batch record review, and compliance on the manufacturing floor, including review of logs, charts, and materials.

Responsibilities include CAPA/Deviation handling, cGMP compliance, and cross-department collaboration. 12-hour shifts are required, with 24/7 oversight support from the QA team.

Competenze

• Exceptional organizational and communication skills; written and oral communication proficiency.
• Bachelor’s Degree preferred, may be offset by experience.
• 3–5 years’ experience in pharmaceutical/biotech or related industry.

Mansioni

• Perform real-time manufacturing batch record review and review of manufacturing documentation.
• Resolve issues on the manufacturing floor and ensure compliance with policies and procedures.
• Review and release plasma pools and raw materials in LIMS/SAP.
• Write, review, and revise QA SOPs and participate in CAPA/Deviations/Change Controls.
• Coordinate and perform training of new employees and provide QA support to other departments.

Conoscenze

Organizational skills

Communication skills

Writing skills

Oral communication

Formazione

Bachelor’s degree

Strumenti

LIMS

SAP

Descrizione del lavoro

ADMA Biologics is seeking a Specialist QA II Manufacturing Oversight in Boca Raton, FL. The role ensures real-time QA oversight, batch record review, and compliance on the manufacturing floor, including review of logs, charts, and materials.

Responsibilities include CAPA/Deviation handling, cGMP compliance, and cross-department collaboration. 12-hour shifts are required, with 24/7 oversight support from the QA team.