Specialist QA I Manufacturing Oversight

ADMA Biologics is a biopharmaceutical company focused on creating superior products for immunodeficient patients at risk for infection. We are a dynamic, innovative, and growing company committed to excellence and integrity.

About the role

The QA Specialist I - Manufacturing Oversight performs manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.

Responsibilities

• Understand and apply 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.
• Apply 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 ensure compliance with SOPs and policies.
• Review and release Plasma pools to manufacturing.
• Review all manufacturing support documentation (logbooks, log sheets, charts, etc.).
• Perform review and release of raw materials in LIMS/SAP.
• Audit the 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 additional activities or projects assigned by QA Management.
• Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers).
• Rotate amongst QA Specialists to provide 24/7 manufacturing oversight coverage.

Requirements

• 1-3 years’ experience in the pharmaceutical or biotechnology industry or other related industry (preferred).
• Bachelor's Degree (preferred but can be offset by experience).
• Ability to follow cGMPs and procedures with great attention to detail.
• Experience with LIMS and SAP (preferred).

Schedule

• 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.

Benefits

• 401K plan with employer match and immediate vesting.
• Medical, Vision, Life, and Dental Insurance.
• Pet Insurance.
• Company-paid Short-Term Disability (STD) and Long-Term Disability (LTD).
• Company-paid holidays.
• 3 weeks’ paid time off (within the first year).
• Tuition assistance (after the first year).
• Easily accessible to Tri-Rail with a free shuttle to the Boca Tri-Rail station.

ADMA Biologics uses E-Verify to confirm employment eligibility and is an Equal Opportunity Employer.