Specialist QA II Manufacturing Oversight

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ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Specialist QA II Manufacturing Oversight in Boca Raton, FL!

Job Title : Specialist QA II Manufacturing Oversight

Job Description : Position Summary

The QA Specialist II - Manufacturing Oversight will perform manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

Essential Functions (ES) and Responsibilities

• Possess and understanding of processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports , Change Controls, and Out of Specifications ).
• Perform Quality Assurance review and approval of Deviation Reports.
• Possess an understanding cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
• Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
• Perform general oversight of Buildings 1 and 2 (including cold rooms / freezers) and their associated activities, as required.
• Review and release of Plasma pools to manufacturing.
• Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
• Review and release of raw materials in LIMS / SAP.
• Perform audits of Nitrogen receipt process.
• Perform notification and disposition of associated Lookback units.
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Write, review, and revise QA SOPs.
• Review SOPs and documents from other departments and provide feedback as necessary.
• Work with other departments to assess if Deviations, CAPAs, and Change Controls are required.
• Assist with training of new employees.
• Coordinate and perform any additional activities or projects assigned by QA Management.
• Experience with LIMS and SAP preferred.

Job Responsibilities or Job Requirements

Competencies

Exceptional organizational and communication skills required

Must have excellent writing and oral skills

Experience Requirements

EDUCATION REQUIREMENTS :

EXPERIENCE REQUIREMENTS :

Preferred Experience

Compliance Requirements (ES)

As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated / escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue.

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In addition to competitive compensation, we offer a comprehensive benefits package including :