Specialist QA II Manufacturing Oversight

BioSpace; Boca Raton (FL); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

401K with match

Medical, Vision, Life

Pet Insurance

STD and LTD

Holidays

Paid Time Off

Tuition Assistance

Shuttle service

Job summary

ADMA Biologics in Boca Raton, FL seeks a Specialist QA II Manufacturing Oversight to lead real-time batch record reviews and ensure adherence to GMP and regulatory requirements on the manufacturing floor.

The role requires 3–5 years in pharma/biotech, familiarity with Quality Systems, CAPAs, Deviations, and Change Controls; experience with LIMS and SAP is preferred, and training new staff will be part of the duties. The QA team provides 24/7 coverage with 12-hour shifts.

Qualifications

• Bachelor's degree in a relevant field, or equivalent experience.
• 3–5 years' experience in pharmaceutical/biotech industries.
• Experience with FDA regulations and GMP a plus.

Responsibilities

• Perform real-time batch record review and documentation oversight.
• Review deviations, CAPAs, change controls, OOSs.
• Ensure compliance with 21 CFR Parts 11, 210, 211, 600.
• Oversee production areas and release of plasma pools.
• Assist with SOPs, training, and QA projects.

Skills

Quality Systems

CAPAs

cGMP

SOPs

Training

Communication

Education

Bachelor's Degree

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 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

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. The QA Specialists team provides 24/7 manufacturing oversight coverage. Specialists are required to work 12‑hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM).

Essential Functions (ES) And Responsibilities

• Possess and understanding of processes such as 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 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: Bachelor's Degree preferred but can be offset by experience.

3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.

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.

Benefits

• 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.