Specialist QA I Manufacturing Oversight

BioSpace; Boca Raton (FL); Presencial; USD 60.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401K plan with employer match

Medical Insurance

Vision Insurance

Life Insurance

Dental Insurance

Pet Insurance

STD and LTD

Holidays

Paid Time Off

Tuition Assistance

Descripción de la vacante

ADMA Biologics in Boca Raton, FL is seeking a Specialist QA I – Manufacturing Oversight. The role conducts real-time batch record reviews, assesses manufacturing documentation, and ensures regulatory compliance on the plant floor.

The ideal candidate has 1–3 years in pharma/biotech, a Bachelor's degree, and a strong understanding of cGMP. The position offers 12-hour shift coverage and a comprehensive benefits package.

Formación

• Familiar with cGMP requirements and quality systems.
• Experience reviewing manufacturing documentation and events.
• Knowledge of regulatory guidelines (FDA) and CAPA processes.

Responsabilidades

• Perform QA review and approval of real-time batch records.
• Inspect active production areas to ensure SOP compliance.
• Review and release plasma pools and raw materials in LIMS/SAP.
• Coordinate with QA management on additional projects.

Conocimientos

Quality Systems

cGMP Compliance

Regulatory Knowledge

Documentation Review

Event Notifications

Educación

Bachelor's Degree

Herramientas

LIMS

SAP

Descripción del empleo

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

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

Job Title: Specialist QA I Manufacturing Oversight

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 {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
• 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 detail

Experience 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:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologics is an Equal Opportunity Employer.