Specialist QA I Manufacturing Oversight

BioSpace; Boca Raton (FL); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

401K with employer match

Medical, Vision, Life and Dental

Pet Insurance

Company paid STD and LTD

Company Paid Holidays

3 Weeks’ Paid Time Off

Tuition Assistance

Free shuttle to Tri-Rail

Job summary

ADMA Biologics in Boca Raton, FL is seeking a Specialist QA I Manufacturing Oversight to perform manufacturing oversight, review batch records, and ensure compliance with cGMP and FDA regulations. The role includes real-time documentation review and support across 12-hour shifts to ensure 24/7 coverage.

Ideal candidates have 1–3 years in pharma/biotech and a Bachelor's degree (or equivalent experience). Training and compliance are emphasized, with strong QA and documentation skills required.

Qualifications

• 1–3 years’ experience in pharmaceutical or biotechnology industry preferred.
• Bachelor's Degree preferred but can be offset by experience.

Responsibilities

• Perform real-time batch record reviews and QA approval of events.
• Review and release plasma pools to manufacturing.
• Oversee compliance with cGMP and regulatory guidelines (21 CFR Part 11, 210, 211, 600).
• Coordinate and perform additional QA oversights and audits as needed.

Skills

Attention to detail

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 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.
• 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.

Experience With LIMS And SAP Is Preferred.

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.

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:

• 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.