Specialist QA I Manufacturing Oversight

ADMA Biologics; Boca Raton, Northern (FL, KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

401K with match

Medical, Vision & Dental insurance

Pet Insurance

STD/LTD

Holidays

Paid Time Off 3 weeks

Tuition Assistance

Shuttle to Tri-Rail

Job summary

ADMA Biologics is seeking a Specialist QA I Manufacturing Oversight in Boca Raton, FL. The role focuses on real-time batch review, documentation oversight, and ensuring compliance with cGMP and FDA requirements.

The Specialist will perform QA review and release activities, oversee production areas, and coordinate inspections. 1–3 years in pharma/biotech and a Bachelor’s degree are preferred; LIMS/SAP experience is a plus. This is a 12-hour shift role with 24/7 coverage rotation.

Qualifications

• Experience in pharmaceutical or biotechnology industry (1–3 years preferred).
• Bachelor's degree preferred but can be offset by experience.
• Strong understanding of FDA regulations and quality systems is required.
• Experience with LIMS and SAP is preferred.

Responsibilities

• Perform QA review and approval of event notifications.
• Oversee and inspect active production areas for GMP and SOP compliance.
• Review and release plasma pools and manufacturing documentation.
• Review and release of raw materials in LIMS/SAP.
• Coordinate with QA management on inspections and CAPAs.
• Provide 24/7 manufacturing oversight coverage on 12-hour shifts.

Skills

Quality systems

cGMP knowledge

Documentation

Education

Bachelor's degree preferred

Tools

LIMS

SAP

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 thebiopharmaceutical industry that is committed toexcellence andintegrity, 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

Job Description:

Position Summary

TheQA Specialist I - Manufacturing Oversightperforms 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 comprehensivebenefits 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 Biologicsis an Equal Opportunity Employer.