Specialist QA I Manufacturing Oversight

Job Details

Job Description

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 QA Specialist I - Manufacturing Oversight in Boca Raton, FL!

Job Title : Specialist QA I Manufacturing Oversight

Job Description : Position Summary

The QA Specialist I - Manufacturing Oversight performs 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 an understanding of Quality Systems (e.g., Deviations, Corrective and Preventive Action reports , Change Controls, and Out of Specifications ).
• Perform Quality Assurance review and approval of Event notifications.
• Possess and understanding of 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.
• Review and release of Plasma pools to manufacturing.
• Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
• Perform review and release of raw materials in LIMS / SAP.
• Perform audits of Nitrogen receipt process.
• Assist with quarantining and release of critical systems, equipment, and controlled environments.
• Assist in other oversight activities, as needed.
• Coordinate and perform any additional activities or projects assigned by QA Management.
• Experience with LIMS and SAP is preferred.
• Perform general oversight of Buildings 1 and 2 (including cold rooms / freezers)
• Rotation amongst QA Specialists to provide 24 / 7 manufacturing oversight coverage. Required to work 12-hour shifts (07 : 00 AM to 07 : 00 PM or 07 : 00 PM to 07 : 00 AM). Must be available to support coverage on either shift.

Job Responsibilities or Job Requirements Competencies Ability to follow the cGMP's and procedures with great attention to detailExperience Requirements

Experience Requirements : 1-3 years' experience in pharmaceutical or biotechnology industry or other related industry preferred

Education Requirements : Bachelor's Degree preferred but can be offset by experience.

Preferred Experience Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer :

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

Company

ADMA Biologics is an end-to-end commercial biopharmaceutical company committed to manufacturing, marketing and developing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for infection. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.

Company info

Website Phone 201-478-5222 Location 5800 Park of Commerce Blvd. NW

Boca Raton, FL 33487

US

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